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FDA 510(k)

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE

K-Number: K881796 · 1988-07-26

ApplicantUniversal Medical Instrument Corp.
Decision Date1988-07-26
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1988-07-26 under 510(k) number K881796. 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 UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE?

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1988-07-26. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K881796.

When did UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE receive FDA 510(k) clearance?

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE received FDA 510(k) clearance on 1988-07-26, under 510(k) number K881796.

Who is the listed applicant for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE?

The FDA product code for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE is DWS.

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Other records listing Universal Medical Instrument Corp. 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK863178UMI STEERABLE TORQUE GUIDE WIREK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTROK860168UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE

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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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