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FDA 510(k)

PRODUCTS IMPLANTABLE PACING LEAD,TINED

K-Number: K823446 · 1982-12-03

ApplicantOscor, Inc.
Decision Date1982-12-03
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRODUCTS IMPLANTABLE PACING LEAD,TINED is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823446. 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 PRODUCTS IMPLANTABLE PACING LEAD,TINED?

PRODUCTS IMPLANTABLE PACING LEAD,TINED is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Oscor, Inc.. The 510(k) number is K823446.

When did PRODUCTS IMPLANTABLE PACING LEAD,TINED receive FDA 510(k) clearance?

PRODUCTS IMPLANTABLE PACING LEAD,TINED received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823446.

Who is the listed applicant for PRODUCTS IMPLANTABLE PACING LEAD,TINED?

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

What is the FDA product code for PRODUCTS IMPLANTABLE PACING LEAD,TINED?

The FDA product code for PRODUCTS IMPLANTABLE PACING LEAD,TINED is DTB.

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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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