Opti-Plast XL 5.5 F Pta Catheter
FDA 510(k) K970725 · Vas-Cath, Inc.
510(k) numberK970725
Submission
- Device name
- Opti-Plast XL 5.5 F Pta Catheter
- Applicant
- Vas-Cath, Inc.
Mississauga, Ontario, CA - Received
- February 28, 1997
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K973013 | Opti-Plast (Centurion) 5.5F Angioplasty CatheterLIT · Traditional | 06/19/1998SE |
| K965178 | Niagara Dual Lumen CatheterMPB · Traditional | 08/19/1997SE |
| K964881 | Ultraverse Pta CatheterLIT · Traditional | 05/28/1997SE |
| K941706 | Opti-Plast Angioplasty CatheterLIT · Traditional | 10/18/1994SE |
| K925485 | Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional | 03/10/1994SE |
| K933483 | Opti-Plast 5F Pta CathetersLIT · Traditional | 09/24/1993SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | 07/01/1993SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | 07/01/1993SE |
| K914976 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 01/27/1992SE |
| K914500 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 12/31/1991SE |
Questions and answers
When was Opti-Plast XL 5.5 F Pta Catheter cleared by the FDA?
Opti-Plast XL 5.5 F Pta Catheter (K970725) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 70 days after the submission was received.
What is the product code of K970725?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.