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FDA 510(k)

MODEL F UNIPOLAR ENDOCARDIAL LEAD-

K-Number: K832255 · 1983-08-12

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

Device Summary

MODEL F UNIPOLAR ENDOCARDIAL 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 K832255. 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 MODEL F UNIPOLAR ENDOCARDIAL LEAD-?

MODEL F UNIPOLAR ENDOCARDIAL 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 K832255.

When did MODEL F UNIPOLAR ENDOCARDIAL LEAD- receive FDA 510(k) clearance?

MODEL F UNIPOLAR ENDOCARDIAL LEAD- received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832255.

Who is the listed applicant for MODEL F UNIPOLAR ENDOCARDIAL 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 MODEL F UNIPOLAR ENDOCARDIAL LEAD-?

The FDA product code for MODEL F UNIPOLAR ENDOCARDIAL 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)

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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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