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FDA 510(k)

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM

K-Number: K801455 · 1980-10-23

ApplicantPacesetter Systems
Decision Date1980-10-23
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801455. 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, ENDOCARDIAL, TINED, BIPOLAR, 5MM?

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Pacesetter Systems. The 510(k) number is K801455.

When did LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM receive FDA 510(k) clearance?

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801455.

Who is the listed applicant for LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM?

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

What is the FDA product code for LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM?

The FDA product code for LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM is DTB.

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Other records listing Pacesetter Systems 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.

K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSK900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TK895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TK891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

View all 96 devices →

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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