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FDA 510(k)

PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)

K-Number: K864167 · 1986-11-06

ApplicantDatascope Corp.
Decision Date1986-11-06
Product Code
DecisionSubstantially Equivalent

Device Summary

PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1986-11-06 under 510(k) number K864167. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)?

PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) is a medical device that received FDA 510(k) clearance on 1986-11-06. The listed applicant is Datascope Corp.. The 510(k) number is K864167.

When did PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) receive FDA 510(k) clearance?

PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) received FDA 510(k) clearance on 1986-11-06, under 510(k) number K864167.

Who is the listed applicant for PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)?

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

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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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