Focus-Pv Balloon Dilatation Catheter
FDA 510(k) K971577 · Cardiovascular Dynamics, Inc.
510(k) numberK971577
Submission
- Device name
- Focus-Pv Balloon Dilatation Catheter
- Applicant
- Cardiovascular Dynamics, Inc.
Irvine, CA, US - Received
- April 21, 1997
- Decision date
- June 18, 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 |
|---|---|---|
| K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…ITX · Traditional | 01/23/1998SE |
| K963989 | P.D. Access (Percutaneous Doppler) Vascular Access DeviceITX · Traditional | 04/24/1997SE |
| K963688 | Focus PV Balloon Dilatation CatheterLIT · Traditional | 03/28/1997SE |
| K945693 | CVD Periflow(Tm) (Small Vessel) Balloon Dilatation CatheterLIT · Traditional | 08/17/1995SE |
| K952064 | Focus Balloon Dilatation CatheterLIT · Traditional | 06/21/1995SE |
| K951502 | CVD Bullet Infusion CatyheterKRA · Traditional | 05/10/1995SE |
| K951503 | CVD Bullett Hi-Flo Infusion CatheterKRA · Traditional | 05/04/1995SE |
| K945465 | CVD Small Vessel Balloon Dilatation CatheterLIT · Traditional | 12/20/1994SE |
| K944016 | Focus Balloon Dilatation CatheterLIT · Traditional | 12/20/1994SE |
| K943023 | CVD Bullett Peripheral Infusion CatheterFOZ · Traditional | 09/30/1994SE |
Questions and answers
When was Focus-Pv Balloon Dilatation Catheter cleared by the FDA?
Focus-Pv Balloon Dilatation Catheter (K971577) received a 510(k) decision of Substantially Equivalent on June 18, 1997, 58 days after the submission was received.
What is the product code of K971577?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.