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FDA 510(k)

MEROGEL INJECTABLE BIORESORBABLE STENT

K-Number: K070886 · 2007-04-26

ApplicantMedtronic, Inc.
Decision Date2007-04-26
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROGEL INJECTABLE BIORESORBABLE STENT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2007-04-26 under 510(k) number K070886. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROGEL INJECTABLE BIORESORBABLE STENT?

MEROGEL INJECTABLE BIORESORBABLE STENT is a medical device that received FDA 510(k) clearance on 2007-04-26. The listed applicant is Medtronic, Inc.. The 510(k) number is K070886.

When did MEROGEL INJECTABLE BIORESORBABLE STENT receive FDA 510(k) clearance?

MEROGEL INJECTABLE BIORESORBABLE STENT received FDA 510(k) clearance on 2007-04-26, under 510(k) number K070886.

Who is the listed applicant for MEROGEL INJECTABLE BIORESORBABLE STENT?

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

What is the FDA product code for MEROGEL INJECTABLE BIORESORBABLE STENT?

The FDA product code for MEROGEL INJECTABLE BIORESORBABLE STENT is NHB.

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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.

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