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FDA 510(k)

CARDICAD(TM)

K-Number: K881392 · 1988-05-31

ApplicantMedical/Surgical Specialties, Ltd.
Decision Date1988-05-31
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDICAD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical/Surgical Specialties, Ltd.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K881392. 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 CARDICAD(TM)?

CARDICAD(TM) is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Medical/Surgical Specialties, Ltd.. The 510(k) number is K881392.

When did CARDICAD(TM) receive FDA 510(k) clearance?

CARDICAD(TM) received FDA 510(k) clearance on 1988-05-31, under 510(k) number K881392.

Who is the listed applicant for CARDICAD(TM)?

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

What is the FDA product code for CARDICAD(TM)?

The FDA product code for CARDICAD(TM) is DWS.

Related Clinical Trials

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Other records listing Medical/Surgical Specialties, 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.

K895677THE MURRAY MOBILIFT(TM)K900633DISP. ELECTROSURGERY PENCIL, HAND CONTROLK881427SPIRIX(TM)

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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