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FDA 510(k)

TB SERIES BIPOLAR PACING LEADS

K-Number: K861403 · 1986-06-27

ApplicantOscor Medical Corp.
Decision Date1986-06-27
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TB SERIES BIPOLAR PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor Medical Corp.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K861403. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TB SERIES BIPOLAR PACING LEADS?

TB SERIES BIPOLAR PACING LEADS is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Oscor Medical Corp.. The 510(k) number is K861403.

When did TB SERIES BIPOLAR PACING LEADS receive FDA 510(k) clearance?

TB SERIES BIPOLAR PACING LEADS received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861403.

Who is the listed applicant for TB SERIES BIPOLAR PACING LEADS?

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

What is the FDA product code for TB SERIES BIPOLAR PACING LEADS?

The FDA product code for TB SERIES BIPOLAR PACING LEADS is LDF.

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Other records listing Oscor Medical Corp. 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.

K964107OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PRK925168MISCELLANEOUS PACING LEADK923621EXTERNAL DEMAND PACEMAKERK912867OSCOR MEDICAL CORP PERMANENT PACING LEADK915008PERMANENT PACING PAD, MODIFICATIONK915007PERMANENT PACING LEADS, MODIFICATION

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Related Devices (Code: LDF)

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, 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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