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FDA 510(k)

LEAD, SUTURELESS MYOCARDIAL

K-Number: K800355 · 1980-05-28

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

Device Summary

LEAD, SUTURELESS MYOCARDIAL is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800355. 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 LEAD, SUTURELESS MYOCARDIAL?

LEAD, SUTURELESS MYOCARDIAL is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Daig Corp.. The 510(k) number is K800355.

When did LEAD, SUTURELESS MYOCARDIAL receive FDA 510(k) clearance?

LEAD, SUTURELESS MYOCARDIAL received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800355.

Who is the listed applicant for LEAD, SUTURELESS MYOCARDIAL?

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 LEAD, SUTURELESS MYOCARDIAL?

The FDA product code for LEAD, SUTURELESS MYOCARDIAL is DTB.

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Other records listing Daig 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.

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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