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FDA 510(k)

MARKERS, STAINLESS STEEL

K-Number: K770802 · 1977-06-27

ApplicantCardio-Surgical, Inc.
Decision Date1977-06-27
Product CodeKPK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MARKERS, STAINLESS STEEL is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Surgical, Inc.. It received FDA 510(k) clearance on 1977-06-27 under 510(k) number K770802. The device is classified under product code KPK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARKERS, STAINLESS STEEL?

MARKERS, STAINLESS STEEL is a medical device that received FDA 510(k) clearance on 1977-06-27. The listed applicant is Cardio-Surgical, Inc.. The 510(k) number is K770802.

When did MARKERS, STAINLESS STEEL receive FDA 510(k) clearance?

MARKERS, STAINLESS STEEL received FDA 510(k) clearance on 1977-06-27, under 510(k) number K770802.

Who is the listed applicant for MARKERS, STAINLESS STEEL?

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

What is the FDA product code for MARKERS, STAINLESS STEEL?

The FDA product code for MARKERS, STAINLESS STEEL is KPK.

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Related Devices (Code: KPK)

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.

K971966CORONARY VEIN GRAFT TAG MARKERMed-Edge, Inc.K895369VOSS GRAFT MARKERVoss Medical ProductsK864919SCANLAN (TM) VEIN/GRAFT HOLDERScanlan Intl., Inc.K864101COOK (R) VEIN GRAFT RING MARKERSCook, Inc.K801637FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.C.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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