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FDA 510(k)

ENDOCARDIAL PACING ELECTRODE

K-Number: K772309 · 1978-02-06

ApplicantCoratomic, Inc.
Decision Date1978-02-06
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCARDIAL PACING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Coratomic, Inc.. It received FDA 510(k) clearance on 1978-02-06 under 510(k) number K772309. 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 ENDOCARDIAL PACING ELECTRODE?

ENDOCARDIAL PACING ELECTRODE is a medical device that received FDA 510(k) clearance on 1978-02-06. The listed applicant is Coratomic, Inc.. The 510(k) number is K772309.

When did ENDOCARDIAL PACING ELECTRODE receive FDA 510(k) clearance?

ENDOCARDIAL PACING ELECTRODE received FDA 510(k) clearance on 1978-02-06, under 510(k) number K772309.

Who is the listed applicant for ENDOCARDIAL PACING ELECTRODE?

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

What is the FDA product code for ENDOCARDIAL PACING ELECTRODE?

The FDA product code for ENDOCARDIAL PACING ELECTRODE is DTB.

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Other records listing Coratomic, Inc. 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.

K863365MODIFICATION OF STERILITY CYCLE PARAMETERSK822791CORATOMIC #VX5-105 & VX5-205 PULSE GEN.K820939C-101-PK821033CORATOMIC MODEL OVALITH-920K821014CORATOMIC MODEL OVALITH 920BPK810808CORATOMIC MODEL OVALITH-920

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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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