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FDA 510(k)

NEEDLE'S EYE SNARE

K-Number: K961992 · 1996-12-27

ApplicantCook Pacemaker Corp.
Decision Date1996-12-27
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEEDLE'S EYE SNARE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Pacemaker Corp.. It received FDA 510(k) clearance on 1996-12-27 under 510(k) number K961992. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE'S EYE SNARE?

NEEDLE'S EYE SNARE is a medical device that received FDA 510(k) clearance on 1996-12-27. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K961992.

When did NEEDLE'S EYE SNARE receive FDA 510(k) clearance?

NEEDLE'S EYE SNARE received FDA 510(k) clearance on 1996-12-27, under 510(k) number K961992.

Who is the listed applicant for NEEDLE'S EYE SNARE?

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

What is the FDA product code for NEEDLE'S EYE SNARE?

The FDA product code for NEEDLE'S EYE SNARE is DXE.

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Related Devices (Code: DXE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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