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Maxi-Torque Plus Angiographic Catheter

by Adam Spence Corp.

510(k) K955111

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955111 Date31 Jan 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after an 84-day FDA review. It received FDA 510(k) clearance K955111 on January 31, 1996, from Adam Spence Corp.

Other devices from Adam Spencer Corp.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER used for?

    The MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER is an intravascular diagnostic catheter used to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels, including for right-heart and left-heart catheterization and angiographic procedures.

  • Who manufactures the MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER and where are they located?

    The MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER is manufactured by Adam Spence Corp., located at 19526 E. Lake Dr., Miami, FL 33015, United States, as indicated in the device authorization records.

  • What regulatory pathway was used to clear the MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER and when was it cleared?

    The MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER was cleared through the Traditional 510(k) pathway after an 84-day FDA review, receiving FDA 510(k) clearance K955111 on January 31, 1996, based on a determination of substantial equivalence.