FDA 510(k)

Bashir S-B Endovascular Catheter, Ref. No. 7101

Número K: K192598 · 2019-10-18

Data da decisão2019-10-18

Código do produtoQEY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2019-10-18 under 510(k) number K192598. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

Bashir S-B Endovascular Catheter, Ref. No. 7101 is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Thrombolex, Inc.. The 510(k) number is K192598.

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

Bashir S-B Endovascular Catheter, Ref. No. 7101 received FDA 510(k) clearance on 2019-10-18, under 510(k) number K192598.

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

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

Ensaios clínicos relacionados

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Outros registros que listam Thrombolex, Inc. como candidato(a)

Dispositivos Relacionados (Código: QEY)

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