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FDA 510(k)

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

K-Number: K951087 · 1995-06-29

ApplicantPacesetter, Inc.
Decision Date1995-06-29
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter, Inc.. It received FDA 510(k) clearance on 1995-06-29 under 510(k) number K951087. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD?

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD is a medical device that received FDA 510(k) clearance on 1995-06-29. The listed applicant is Pacesetter, Inc.. The 510(k) number is K951087.

When did TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD receive FDA 510(k) clearance?

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD received FDA 510(k) clearance on 1995-06-29, under 510(k) number K951087.

Who is the listed applicant for TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD?

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

What is the FDA product code for TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD?

The FDA product code for TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD is DTB.

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Other records listing Pacesetter, 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.

K972814LOCATOR MODEL 4036K960854SIEMENS SERVO ULTRA NEBULIZER 345K954714AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)K954551DF-1 TERMINAL CAPK951950PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGK952206PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

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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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