Opti-Plast 5F PTA Catheters

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

510(k) Number

K910996 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vas-Cath Inc. Opti-Plast Angioplasty Catheter

  Class II

  FDA 510(k) K925485 Active Cleared 10 Mar 1994

• Opti-Plast 5F PTA Catheters Oven Curing Procedure

  Class II

  FDA 510(k) K911639 Active Cleared 11 Jun 1991

• Vas-Cath Ureteral Stents Catheter, Modification

  Class II

  FDA 510(k) K905505 Active Cleared 9 Apr 1991

• Opti-Plast 5F PTA Catheters, Modification

  Class II

  FDA 510(k) K914500 Active Cleared 31 Dec 1991

• Ultraverse PTA Catheter

  Class II

  FDA 510(k) K964881 Active Cleared 28 May 1997

• Opti-Plast (Centurion) 5.5F Angioplasty Catheter

  Class II

  FDA 510(k) K973013 Active Cleared 19 Jun 1998

See all devices from Vas-Cath, Inc. →

• What is the Opti-Plast 5F PTA Catheter used for?

  The Opti-Plast 5F PTA Catheter is designed for use in cardiovascular procedures to dilate narrowed or obstructed peripheral arteries, as stated in its description for peripheral transluminal angioplasty.

• Is the Opti-Plast 5F PTA Catheter sterile and for single-use only?

  Yes, the device is supplied sterile and intended for single-use only, as explicitly specified in the device data under its description and specifications.

• What regulatory pathway was used for the Opti-Plast 5F PTA Catheter?

  The Opti-Plast 5F PTA Catheter received FDA 510(k) clearance (K910996) on April 9, 1991, through a traditional clearance process, as indicated in the AUTHORIZATIONS and decision_description fields.

• What is the product code and regulation number for the Opti-Plast 5F PTA Catheter?

  The product code is LIT and it falls under regulation number 870.1250, as listed in the SPECIFICATIONS section of the device data.