FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Prestige Coil System (Prestige Packing Line Extension)
K Number: K251383
·
Decision May 30, 2025
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
18
Review Days
28
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Basic Information
- Device Name
- Prestige Coil System (Prestige Packing Line Extension)
- K Number
- K251383
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Balt USA, LLC
- Date Received
- May 2, 2025
- Decision Date
- May 30, 2025
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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Other Clearances by Balt USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K254223 | Next Generation 088 Catheter | Apr 16, 2026 | Substantially Equivalent |
| K254221 | Optima Coil System (OptiOne Coil System) | Jan 27, 2026 | Substantially Equivalent |
| K252569 | Carrier XL Delivery Catheter | Oct 22, 2025 | Substantially Equivalent |
| K252700 | Optima Coil System (Optima Packing Coil System) | Sep 26, 2025 | Substantially Equivalent |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Jun 3, 2025 | Substantially Equivalent |
| K242376 | Next Generation Access Platform | Dec 30, 2024 | Substantially Equivalent |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Sep 27, 2024 | Substantially Equivalent |
| K234074 | Next Generation Access Catheter | Jul 2, 2024 | Substantially Equivalent |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Jul 2, 2024 | Substantially Equivalent |
| K230609 | NG Delivery Catheter | Sep 13, 2023 | Substantially Equivalent |