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FDA 510(k)

ELECTRODE, TEMPORARY MYOCARDIAL

K-Number: K760513 · 1976-10-15

ApplicantWinn Hirsch & Assoc.
Decision Date1976-10-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE, TEMPORARY MYOCARDIAL is the device name listed in this FDA 510(k) record. The listed applicant is Winn Hirsch & Assoc.. It received FDA 510(k) clearance on 1976-10-15 under 510(k) number K760513. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE, TEMPORARY MYOCARDIAL?

ELECTRODE, TEMPORARY MYOCARDIAL is a medical device that received FDA 510(k) clearance on 1976-10-15. The listed applicant is Winn Hirsch & Assoc.. The 510(k) number is K760513.

When did ELECTRODE, TEMPORARY MYOCARDIAL receive FDA 510(k) clearance?

ELECTRODE, TEMPORARY MYOCARDIAL received FDA 510(k) clearance on 1976-10-15, under 510(k) number K760513.

Who is the listed applicant for ELECTRODE, TEMPORARY MYOCARDIAL?

The FDA 510(k) record lists Winn Hirsch & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRODE, TEMPORARY MYOCARDIAL?

The FDA product code for ELECTRODE, TEMPORARY MYOCARDIAL is DTB.

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Other records listing Winn Hirsch & Assoc. 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.

K880309TYPE 316L STAINLESS STEEL WIREK864375TYPE 316L COTTER WIREK832214GAUZE CONVERSION CLASS I-NON-STERILEK832213GAUZE CONVERSION CLASS II STERILEK830511ZANLEX, ZAN-TEX & ZANDEXK812390NEUROSPONGE PADDIE

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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