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FDA 510(k)

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN

K-Number: K802553 · 1981-01-16

ApplicantDaig Corp.
Decision Date1981-01-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K802553. 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 PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN?

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Daig Corp.. The 510(k) number is K802553.

When did PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN receive FDA 510(k) clearance?

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN received FDA 510(k) clearance on 1981-01-16, under 510(k) number K802553.

Who is the listed applicant for PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN?

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 PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN?

The FDA product code for PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN 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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