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FDA 510(k)

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

K-Number: K874367 · 1988-01-04

ApplicantSpembly Medical , Ltd.
Decision Date1988-01-04
Product CodeHQO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1988-01-04 under 510(k) number K874367. The device is classified under product code HQO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF?

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF is a medical device that received FDA 510(k) clearance on 1988-01-04. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K874367.

When did VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF receive FDA 510(k) clearance?

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF received FDA 510(k) clearance on 1988-01-04, under 510(k) number K874367.

Who is the listed applicant for VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF?

The FDA 510(k) record lists Spembly Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF?

The FDA product code for VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF is HQO.

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Other records listing Spembly Medical , Ltd. as applicant

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.

K925129SELECTORK903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)K882963SPEMBLY MEDICAL 142 CRYO UNIT

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Related Devices (Code: HQO)

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.

K070871STARION UNIVERSAL POWER SUPPLYStarion InstrumentsK043155STARION UNIVERSAL POWER SUPPLY (UPS)Starion InstrumentsK002341THERMAL CAUTERY UNIT, MODEL 150Geiger Medical Technologies, Inc.K000893AC POWERED THERMAL CAUTERY UNITStarion InstrumentsK971538MENTOR GEMINI HEMOSTATIC ERASERMentor Ophthalmics, Inc.K962135D.O.R.C. MICRODIATHERMY SYSTEMDutch Ophthalmic USA, 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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