M-CATH Flexy 135 cm

Organization name

Acrostak (Schweiz) AG

SRN

CH-MF-000011424

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• This product is intended for single use only. Do NOT reprocess, resterilise and/or reuse.

  OTHER

• Do not use if the sterile package is opened or damaged.

  OTHER

• Contra-indications: patients with previous coronary artery spasm; not to be used for high pressure injections or in neurovasculature; not to be used for delivery of embolic materials; not to be used in institutions where emergency coronary artery bypass graft surgery (CABG) cannot be performed; not to be used in patients for whom the procedure is considered unsuitable by the physician.

  OTHER

• Processing and/or resterilisation measures can harm the characteristics of the catheter due to chemical, thermal and mechanical stresses. Furthermore, after reprocessing, there is an increased risk of contamination of the product as well as infection or cross-infection of the patient.

  OTHER

• Take care while handling and torquing the catheter during a procedure to reduce the possibility of accidental breakage, separation or kinking of the product. Do not turn the microcatheter excessively if it is bent, as this could break or damage the product.

  OTHER

• During the procedure, the catheter should only be manipulated under fluoroscopy. Never advance or withdraw the microcatheter against resistance until the cause of the resistance is determined by fluoroscopy. If not, the microcatheter and/or the guidewire could be damaged.

  OTHER

• Do not turn the microcatheter in the same direction, either clockwise or counterclockwise, for more than 5 consecutive turns, while the catheter tip is adjacent to the stenotic lesion. If resistance is observed, stop the movement and determine the cause of the resistance under fluoroscopy. Otherwise, the catheter or the vessels could be damaged, endangering the life of the patient.

  OTHER

Primary placement in Austria; available across 12 countries total.

Trade name

M-CATH Flexy 135 cm

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07640132622690

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-07640132622690

Reference / catalog number

820135732

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

M-CATH Flexy consists of a flexible polymer shaft with a stainless-steel braiding, a low-profile tapered tip, and a hub. The outer surface of the catheter is coated with a hydrophilic polymer having a high lubricity upon moistening, hence, enhancing manoeuvrability and patient comfort. The microcatheter has one distal radiopaque marker near the distal tip. The shaft has a central guidewire lumen which permits the use of a guidewire with maximum diameter of 0.014" (0.36 mm). The guidewire lumen begins at the proximal luer port and ends at the distal tip.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 135 MU10

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C0104010299CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.