FDA 510(k)

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

K-Nummer: K222095 · 2023-04-20

Entscheidungsdatum2023-04-20

ProduktcodeQEY

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K222095. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Thrombolex, Inc.. The 510(k) number is K222095.

When did BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 receive FDA 510(k) clearance?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 received FDA 510(k) clearance on 2023-04-20, under 510(k) number K222095.

Who is the listed applicant for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

The FDA 510(k) record lists Thrombolex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

The FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is QEY.

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