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FDA 510(k)

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

K-Number: K944957 · 1995-07-14

ApplicantMedtronic Blood Systems, Inc.
Decision Date1995-07-14
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Systems, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K944957. 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 TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500?

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K944957.

When did TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 receive FDA 510(k) clearance?

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 received FDA 510(k) clearance on 1995-07-14, under 510(k) number K944957.

Who is the listed applicant for TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500?

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

What is the FDA product code for TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500?

The FDA product code for TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 is LDF.

Related Clinical Trials

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Other records listing Medtronic Blood Systems, 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.

K944966UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492K893207CLOSED CHEST SUPPORT CIRCUITK893678DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601HK891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEK891230MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM

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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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