FDA 510(k)

IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS

K-Number: K073148 · 2007-12-07

ApplicantPower Medical Interventions, Inc.

Decision Date2007-12-07

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Power Medical Interventions, Inc.. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K073148. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS?

IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K073148.

When did IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS receive FDA 510(k) clearance?

IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS received FDA 510(k) clearance on 2007-12-07, under 510(k) number K073148.

Who is the listed applicant for IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS?

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

What is the FDA product code for IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS?

The FDA product code for IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS is GDW.

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Other records listing Power Medical Interventions, Inc. as applicant

K091215INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT K083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS K081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V K073001IDRIVES, IDRIVEC, IDRIVEF K071708I45, I45S, I60, AND I60S K063746POWER EXTENDERS MODEL# PEC200, PES200,PES200S

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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.