FDA 510(k)

MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE

K-Number: K935814 · 1994-03-14

Decision Date1994-03-14

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE 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 1994-03-14 under 510(k) number K935814. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE?

MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Boston Scientific Corp. The 510(k) number is K935814.

When did MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE receive FDA 510(k) clearance?

MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE received FDA 510(k) clearance on 1994-03-14, under 510(k) number K935814.

Who is the listed applicant for MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE?

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 MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE?

The FDA product code for MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE is KNW.

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Official Source

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