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FDA 510(k)

MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD

K-Number: K883265 · 1988-10-14

ApplicantTelectronics and Cordis Pacing Systems
Decision Date1988-10-14
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics and Cordis Pacing Systems. It received FDA 510(k) clearance on 1988-10-14 under 510(k) number K883265. 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 MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD?

MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD is a medical device that received FDA 510(k) clearance on 1988-10-14. The listed applicant is Telectronics and Cordis Pacing Systems. The 510(k) number is K883265.

When did MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD receive FDA 510(k) clearance?

MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD received FDA 510(k) clearance on 1988-10-14, under 510(k) number K883265.

Who is the listed applicant for MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD?

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

What is the FDA product code for MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD?

The FDA product code for MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD is DTB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Telectronics and Cordis Pacing 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.

K881904CHANGE TO CATHODE POWDER SPECIFICATIONK881711VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.

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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