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FDA 510(k)

SUTURELESS TEMPORARY EPICARDIAL PACING LEAD

K-Number: K873474 · 1987-10-07

ApplicantSymbion, Inc.
Decision Date1987-10-07
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUTURELESS TEMPORARY EPICARDIAL PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Symbion, Inc.. It received FDA 510(k) clearance on 1987-10-07 under 510(k) number K873474. 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 SUTURELESS TEMPORARY EPICARDIAL PACING LEAD?

SUTURELESS TEMPORARY EPICARDIAL PACING LEAD is a medical device that received FDA 510(k) clearance on 1987-10-07. The listed applicant is Symbion, Inc.. The 510(k) number is K873474.

When did SUTURELESS TEMPORARY EPICARDIAL PACING LEAD receive FDA 510(k) clearance?

SUTURELESS TEMPORARY EPICARDIAL PACING LEAD received FDA 510(k) clearance on 1987-10-07, under 510(k) number K873474.

Who is the listed applicant for SUTURELESS TEMPORARY EPICARDIAL PACING LEAD?

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

What is the FDA product code for SUTURELESS TEMPORARY EPICARDIAL PACING LEAD?

The FDA product code for SUTURELESS TEMPORARY EPICARDIAL PACING LEAD is LDF.

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.

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Other records listing Symbion, 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.

K882129SYMBION CENTRIFUGAL BLOOD PUMP MODEL I

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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