Decision Date2004-09-02
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
DETECT SURGICAL PACING AND MAPPING TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2004-09-02 under 510(k) number K040812. 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 DETECT SURGICAL PACING AND MAPPING TOOL?
DETECT SURGICAL PACING AND MAPPING TOOL is a medical device that received FDA 510(k) clearance on 2004-09-02. The listed applicant is Medtronic Vascular. The 510(k) number is K040812.
When did DETECT SURGICAL PACING AND MAPPING TOOL receive FDA 510(k) clearance?
DETECT SURGICAL PACING AND MAPPING TOOL received FDA 510(k) clearance on 2004-09-02, under 510(k) number K040812.
Who is the listed applicant for DETECT SURGICAL PACING AND MAPPING TOOL?
The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DETECT SURGICAL PACING AND MAPPING TOOL?
The FDA product code for DETECT SURGICAL PACING AND MAPPING TOOL 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.
Other records listing Medtronic Vascular 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.
K232570Steerant™ Super Stiff GuidewireK2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterK2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding CatheterK173515Admiral Xtreme View all 474 devices →
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.