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FDA 510(k)

LOCATOR MODEL 4036

K-Number: K972814 · 1998-02-23

ApplicantPacesetter, Inc.
Decision Date1998-02-23
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

LOCATOR MODEL 4036 is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter, Inc.. It received FDA 510(k) clearance on 1998-02-23 under 510(k) number K972814. 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 LOCATOR MODEL 4036?

LOCATOR MODEL 4036 is a medical device that received FDA 510(k) clearance on 1998-02-23. The listed applicant is Pacesetter, Inc.. The 510(k) number is K972814.

When did LOCATOR MODEL 4036 receive FDA 510(k) clearance?

LOCATOR MODEL 4036 received FDA 510(k) clearance on 1998-02-23, under 510(k) number K972814.

Who is the listed applicant for LOCATOR MODEL 4036?

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 LOCATOR MODEL 4036?

The FDA product code for LOCATOR MODEL 4036 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.

K960854SIEMENS 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 COATINGK951087TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

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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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