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FDA 510(k)

UNIPOLAR-E ENDOCARDIAL TINED LEAD

K-Number: K832245 · 1983-08-12

ApplicantCook Pacemaker Corp.
Decision Date1983-08-12
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR-E ENDOCARDIAL TINED LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Cook Pacemaker Corp.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832245. 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 UNIPOLAR-E ENDOCARDIAL TINED LEAD?

UNIPOLAR-E ENDOCARDIAL TINED LEAD is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K832245.

When did UNIPOLAR-E ENDOCARDIAL TINED LEAD receive FDA 510(k) clearance?

UNIPOLAR-E ENDOCARDIAL TINED LEAD received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832245.

Who is the listed applicant for UNIPOLAR-E ENDOCARDIAL TINED LEAD?

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

What is the FDA product code for UNIPOLAR-E ENDOCARDIAL TINED LEAD?

The FDA product code for UNIPOLAR-E ENDOCARDIAL TINED LEAD is DTB.

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Other records listing Cook Pacemaker Corp. 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.

K970690LOCKING STYLET 2K961992NEEDLE'S EYE SNAREK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSK915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEADK905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMERK863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

View all 34 devices →

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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