FDA 510(k)

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD

K-Number: K885179 · 1989-08-09

Decision Date1989-08-09

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K885179. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD?

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K885179.

When did INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD receive FDA 510(k) clearance?

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD received FDA 510(k) clearance on 1989-08-09, under 510(k) number K885179.

Who is the listed applicant for INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD?

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

What is the FDA product code for INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD?

The FDA product code for INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD is DYB.

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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.