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FDA 510(k)

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR

K-Number: K851152 · 1985-06-24

ApplicantCryomedics, Inc.
Decision Date1985-06-24
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedics, Inc.. It received FDA 510(k) clearance on 1985-06-24 under 510(k) number K851152. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR?

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Cryomedics, Inc.. The 510(k) number is K851152.

When did MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR receive FDA 510(k) clearance?

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR received FDA 510(k) clearance on 1985-06-24, under 510(k) number K851152.

Who is the listed applicant for MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR?

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

What is the FDA product code for MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR?

The FDA product code for MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR is DWS.

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Other records listing Cryomedics, Inc. 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.

K844431YN CO2 LASER SYSTEM 30WK842888DUAL CHANNEL TENS, PULSAR REMOTE CONTRLK842959MC-4000 CONSOLE & PROBESK842704MT-700 MT-750 FT-350K801730KRYMED SYSTEM 4001 TILT SCOPEK800335KRYMED LIQUID NITROGEN CRYOJET

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Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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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