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FDA 510(k)

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

K-Number: K780246 · 1978-08-31

ApplicantDaig Corp.
Decision Date1978-08-31
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER, ELECTRODE, PERMANENT & TEMP. is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K780246. 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 PACEMAKER, ELECTRODE, PERMANENT & TEMP.?

PACEMAKER, ELECTRODE, PERMANENT & TEMP. is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Daig Corp.. The 510(k) number is K780246.

When did PACEMAKER, ELECTRODE, PERMANENT & TEMP. receive FDA 510(k) clearance?

PACEMAKER, ELECTRODE, PERMANENT & TEMP. received FDA 510(k) clearance on 1978-08-31, under 510(k) number K780246.

Who is the listed applicant for PACEMAKER, ELECTRODE, PERMANENT & TEMP.?

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 PACEMAKER, ELECTRODE, PERMANENT & TEMP.?

The FDA product code for PACEMAKER, ELECTRODE, PERMANENT & TEMP. is DTB.

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Other records listing Daig Corp. as applicant

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K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXK982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETERK982187FAST-CATH INTRA-CARDIAC INTRODUCERK973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERK964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

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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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