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FDA 510(k)

HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK

K-Number: K882045 · 1988-07-12

ApplicantCordis Leads, Inc.
Decision Date1988-07-12
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Leads, Inc.. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K882045. 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 HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK?

HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Cordis Leads, Inc.. The 510(k) number is K882045.

When did HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK receive FDA 510(k) clearance?

HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882045.

Who is the listed applicant for HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK?

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

What is the FDA product code for HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK?

The FDA product code for HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK is LDF.

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Other records listing Cordis Leads, Inc. 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.

K883070ENCOR UNIPOLAR VS-1 LEADSK873772CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADSK874366ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201

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

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