Bipore Balloon Dilatation Catheter
FDA 510(k) K973563 · Bipore, Inc.
510(k) numberK973563
Submission
- Device name
- Bipore Balloon Dilatation Catheter
- Applicant
- Bipore, Inc.
Northvale, NJ, US - Received
- September 19, 1997
- Decision date
- April 1, 1998
- 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 |
|---|---|---|
| K073434 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Special | 04/01/2008SE |
| K073318 | Bipore Balloon Dilation CatheterLIT · Special | 01/16/2008SE |
| K051513 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Abbreviated | 12/07/2005SE |
| K041293 | Biopore Balloon Dilation CatheterLIT · Abbreviated | 07/09/2004SE |
| K983650 | Bipore Balloon Dilatation CatheterLIT · Traditional | 02/17/1999SE |
| K964814 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Traditional | 05/07/1997SE |
| K961980 | Bipore Balloon Dilatation CatheterLIT · Traditional | 09/12/1996SE |
| K862015 | O.2 Micron Infection Resistant Hydrophobic FilterFIB · Traditional | 07/22/1986SE |
| K844625 | Bipore O.2 Micron Hydrophobic Filter AssemblyKOZ · Traditional | 01/16/1985SE |
Questions and answers
When was Bipore Balloon Dilatation Catheter cleared by the FDA?
Bipore Balloon Dilatation Catheter (K973563) received a 510(k) decision of Substantially Equivalent on April 1, 1998, 194 days after the submission was received.
What is the product code of K973563?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.