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FDA 510(k)

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1

K-Number: K884866 · 1989-03-22

ApplicantOscor Medical Corp.
Decision Date1989-03-22
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 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 1989-03-22 under 510(k) number K884866. 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 TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1?

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Oscor Medical Corp.. The 510(k) number is K884866.

When did TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 receive FDA 510(k) clearance?

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 received FDA 510(k) clearance on 1989-03-22, under 510(k) number K884866.

Who is the listed applicant for TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1?

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 TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1?

The FDA product code for TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 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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