Noprofile Olbert Catheter System Balloon Dilatation Catheter
FDA 510(k) K952884 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK952884
Submission
- Device name
- Noprofile Olbert Catheter System Balloon Dilatation Catheter
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- June 23, 1995
- Decision date
- February 21, 1996
- 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 |
|---|---|---|
| K953647 | MS Classique Balloon Catheter W/Hydropass CoatingLIT · Traditional | 05/16/1997SE |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | 03/19/1997ST |
| K962433 | Meadox Exxcel Eptfe Vascular GraftDSY · Traditional | 03/17/1997ST |
| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K954848 | Hemashield Microvel Velour Knitted Vascular GraftMAL · Traditional | 02/01/1996ST |
| K953608 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 12/20/1995SE |
Questions and answers
When was Noprofile Olbert Catheter System Balloon Dilatation Catheter cleared by the FDA?
Noprofile Olbert Catheter System Balloon Dilatation Catheter (K952884) received a 510(k) decision of Substantially Equivalent on February 21, 1996, 243 days after the submission was received.
What is the product code of K952884?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.