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FDA 510(k)

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)

K-Number: K760151 · 1976-08-26

ApplicantEdwards Laboratories
Decision Date1976-08-26
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1976-08-26 under 510(k) number K760151. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)?

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) is a medical device that received FDA 510(k) clearance on 1976-08-26. The listed applicant is Edwards Laboratories. The 510(k) number is K760151.

When did APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) receive FDA 510(k) clearance?

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) received FDA 510(k) clearance on 1976-08-26, under 510(k) number K760151.

Who is the listed applicant for APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)?

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

What is the FDA product code for APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)?

The FDA product code for APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) is DTK.

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Other records listing Edwards Laboratories 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.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESIS

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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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