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FDA 510(k)

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

K-Number: K013339 · 2001-11-08

ApplicantOscor, Inc.
Decision Date2001-11-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K013339. 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 PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS?

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Oscor, Inc.. The 510(k) number is K013339.

When did PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS receive FDA 510(k) clearance?

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS received FDA 510(k) clearance on 2001-11-08, under 510(k) number K013339.

Who is the listed applicant for PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS?

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

What is the FDA product code for PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS?

The FDA product code for PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS is DTB.

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Other records listing Oscor, Inc. as applicant

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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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