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FDA 510(k)

ENDOCARD. PACING LEAD STD. LENGTH PL202

K-Number: K800350 · 1980-05-28

ApplicantDaig Corp.
Decision Date1980-05-28
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCARD. PACING LEAD STD. LENGTH PL202 is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800350. 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 ENDOCARD. PACING LEAD STD. LENGTH PL202?

ENDOCARD. PACING LEAD STD. LENGTH PL202 is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Daig Corp.. The 510(k) number is K800350.

When did ENDOCARD. PACING LEAD STD. LENGTH PL202 receive FDA 510(k) clearance?

ENDOCARD. PACING LEAD STD. LENGTH PL202 received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800350.

Who is the listed applicant for ENDOCARD. PACING LEAD STD. LENGTH PL202?

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

What is the FDA product code for ENDOCARD. PACING LEAD STD. LENGTH PL202?

The FDA product code for ENDOCARD. PACING LEAD STD. LENGTH PL202 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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