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FDA 510(k)

CARDIOVASCULAR SURGICAL INSTRUMENTS

K-Number: K874960 · 1988-02-05

ApplicantSolway, Inc.
Decision Date1988-02-05
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Solway, Inc.. It received FDA 510(k) clearance on 1988-02-05 under 510(k) number K874960. 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 CARDIOVASCULAR SURGICAL INSTRUMENTS?

CARDIOVASCULAR SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1988-02-05. The listed applicant is Solway, Inc.. The 510(k) number is K874960.

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

CARDIOVASCULAR SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1988-02-05, under 510(k) number K874960.

Who is the listed applicant for CARDIOVASCULAR SURGICAL INSTRUMENTS?

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

What is the FDA product code for CARDIOVASCULAR SURGICAL INSTRUMENTS?

The FDA product code for CARDIOVASCULAR SURGICAL INSTRUMENTS is DWS.

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Other records listing Solway, 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.

K874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASK874956SELF-RETAINING RETRACTOR FOR NEUROSURGERYK874964DENTAL HAND INSTRUMENTSK875043RONGEUR (NEUROSURGICAL INSTRUMENTS)K874966TUNING FORKSK874950MICROSURGICAL INSTRUMENTS

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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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