FDA 510(k)

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

N.º K: K192598 · 2019-10-18

Fecha de decisión2019-10-18

Código de productoQEY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Thrombolex, Inc. como solicitante

Dispositivos relacionados (Código: QEY)

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

Fuente oficial

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