IVT Coronary Atherectomy System TEC

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Ivt Coronary Atherectomy System (Tec)(R)

Generic Name

CATHETER, CORONARY, ATHERECTOMY

PMA Number

P910019 ↗

FDA Product Code

MCX

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APWD Approval withdrawn

• Modified Ivt Peripheral Atherectomy

  Class II

  FDA 510(k) K901767 Active Cleared 28 Jun 1990

• Ivt Introducer Sheath

  Class II

  FDA 510(k) K903463 Active Cleared 3 Jan 1991

• Peripheral Atherectomy System

  Class II

  FDA 510(k) K890515 Active Cleared 23 May 1989

• Aptt by Hemochron(R)

  Class II

  FDA 510(k) K892209 Active Cleared 22 Jun 1989

• Modified Ivt Peripheral Atherectomy System

  Class II

  FDA 510(k) K896403 Active Cleared 6 Mar 1990

• Hemochron(R) Heparin Response Test

  Class II

  FDA 510(k) K904003 Active Cleared 29 Nov 1990

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