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FDA 510(k)

ENDOCARD. PACING LEAD LONG LENGTH PL200

K-Number: K800349 · 1980-05-28

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

Device Summary

ENDOCARD. PACING LEAD LONG LENGTH PL200 is the device name listed in this FDA 510(k) record. The listed applicant is Diag Corp.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800349. 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 LONG LENGTH PL200?

ENDOCARD. PACING LEAD LONG LENGTH PL200 is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diag Corp.. The 510(k) number is K800349.

When did ENDOCARD. PACING LEAD LONG LENGTH PL200 receive FDA 510(k) clearance?

ENDOCARD. PACING LEAD LONG LENGTH PL200 received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800349.

Who is the listed applicant for ENDOCARD. PACING LEAD LONG LENGTH PL200?

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

What is the FDA product code for ENDOCARD. PACING LEAD LONG LENGTH PL200?

The FDA product code for ENDOCARD. PACING LEAD LONG LENGTH PL200 is DTB.

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Other records listing Diag Corp. as applicant

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K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCERK910645DISPOSABLE PATIENT CABLEK852446ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIPK820003CARDIOVASCULAR TEMP. PACEMAKER ELECK820262PERMANENT & TEMPORARY PACEMAKER ELECTR.

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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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