FDA 510(k)

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER

K-Number: K030966 · 2003-09-23

Decision Date2003-09-23

Product CodeNAJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K030966. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER?

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Boston Scientific Corp. The 510(k) number is K030966.

When did CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER receive FDA 510(k) clearance?

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER received FDA 510(k) clearance on 2003-09-23, under 510(k) number K030966.

Who is the listed applicant for CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER?

The FDA product code for CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER is NAJ.

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Related Devices (Code: NAJ)

K233813Bearing nsPVA Express™Merit Medical Systems, Inc.K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.K130259BEARING NSPVA EMBOLIZATION PARTICLESMerit Medical Systems, Inc.K100663CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321Boston Scientific Corporation K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLESCook Incorporated K021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATIONBiosphere Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.