Prestige Coil System (Prestige Packing Line Extension)
FDA 510(k) K251383 · Balt USA, LLC
510(k) numberK251383
Submission
- Device name
- Prestige Coil System (Prestige Packing Line Extension)
- Applicant
- Balt USA, LLC
Irvine, CA, US - Received
- May 2, 2025
- Decision date
- May 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260199 | SLIM MicrocatheterQJP · Traditional | 07/13/2026SE |
| K254223 | Next Generation 088 CatheterQJP · Traditional | 04/16/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | 01/27/2026SE |
| K252569 | Carrier XL Delivery CatheterQJP · Special | 10/22/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | 09/26/2025SE |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 06/03/2025SE |
| K242376 | Next Generation Access PlatformQJP · Traditional | 12/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | 09/27/2024SE |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 07/02/2024SE |
| K234074 | Next Generation Access CatheterQJP · Traditional | 07/02/2024SE |
Questions and answers
When was Prestige Coil System (Prestige Packing Line Extension) cleared by the FDA?
Prestige Coil System (Prestige Packing Line Extension) (K251383) received a 510(k) decision of Substantially Equivalent on May 30, 2025, 28 days after the submission was received.
What is the product code of K251383?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.