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FDA 510(k)

PRESTITCH

K-Number: K910449 · 1992-05-29

ApplicantCrantec Co.
Decision Date1992-05-29
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRESTITCH is the device name listed in this FDA 510(k) record. The listed applicant is Crantec Co.. It received FDA 510(k) clearance on 1992-05-29 under 510(k) number K910449. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESTITCH?

PRESTITCH is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is Crantec Co.. The 510(k) number is K910449.

When did PRESTITCH receive FDA 510(k) clearance?

PRESTITCH received FDA 510(k) clearance on 1992-05-29, under 510(k) number K910449.

Who is the listed applicant for PRESTITCH?

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

What is the FDA product code for PRESTITCH?

The FDA product code for PRESTITCH is KCY.

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.

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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