FDA 510(k)

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540

K-Number: K864507 · 1987-03-06

Decision Date1987-03-06

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K864507. 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 V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540?

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Spectramed, Inc.. The 510(k) number is K864507.

When did V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 receive FDA 510(k) clearance?

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 received FDA 510(k) clearance on 1987-03-06, under 510(k) number K864507.

Who is the listed applicant for V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540?

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

What is the FDA product code for V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540?

The FDA product code for V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spectramed, Inc. as applicant

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267 K895323MODEL DT-BAL, BALANCE SAVER K894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP K881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

View all 13 devices →

Related Devices (Code: LDF)

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.