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FDA 510(k)

BIOSURGE MODEL ILVC-1

K-Number: K875016 · 1988-02-29

ApplicantBiosurge, Inc.
Decision Date1988-02-29
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSURGE MODEL ILVC-1 is the device name listed in this FDA 510(k) record. The listed applicant is Biosurge, Inc.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K875016. 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 BIOSURGE MODEL ILVC-1?

BIOSURGE MODEL ILVC-1 is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Biosurge, Inc.. The 510(k) number is K875016.

When did BIOSURGE MODEL ILVC-1 receive FDA 510(k) clearance?

BIOSURGE MODEL ILVC-1 received FDA 510(k) clearance on 1988-02-29, under 510(k) number K875016.

Who is the listed applicant for BIOSURGE MODEL ILVC-1?

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

What is the FDA product code for BIOSURGE MODEL ILVC-1?

The FDA product code for BIOSURGE MODEL ILVC-1 is DWS.

Related Clinical Trials

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Other records listing Biosurge, 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.

K884620ASD SINGLE LUMEN NEEDLEK874602ASD-BIO ANTI-STICK DEVICEK875023BIOSURGE MODEL OASYS-IIK871258BIOSURGE MODEL OASYS

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

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