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FDA 510(k)

BRISTOL BALLON INTRODUCER, MANDRIL SET

K-Number: K813332 · 1981-12-14

ApplicantInmed Corp.
Decision Date1981-12-14
Product CodeNWU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BRISTOL BALLON INTRODUCER, MANDRIL SET is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813332. The device is classified under product code NWU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRISTOL BALLON INTRODUCER, MANDRIL SET?

BRISTOL BALLON INTRODUCER, MANDRIL SET is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Inmed Corp.. The 510(k) number is K813332.

When did BRISTOL BALLON INTRODUCER, MANDRIL SET receive FDA 510(k) clearance?

BRISTOL BALLON INTRODUCER, MANDRIL SET received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813332.

Who is the listed applicant for BRISTOL BALLON INTRODUCER, MANDRIL SET?

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

What is the FDA product code for BRISTOL BALLON INTRODUCER, MANDRIL SET?

The FDA product code for BRISTOL BALLON INTRODUCER, MANDRIL SET is NWU.

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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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