FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇺 Mauritius
Amethyst HP PTA OTW 0.035 Catheter
K Number: K251915
·
Decision Dec 18, 2025
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
11
Review Days
178
Basic Information
- Device Name
- Amethyst HP PTA OTW 0.035 Catheter
- K Number
- K251915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natec Medical , Ltd.
- Date Received
- June 23, 2025
- Decision Date
- December 18, 2025
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Natec Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Dec 18, 2024 | Substantially Equivalent |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Jun 29, 2022 | Substantially Equivalent |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Jul 9, 2021 | Substantially Equivalent |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Jun 28, 2015 | Substantially Equivalent |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter | Jun 4, 2015 | Substantially Equivalent |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Mar 30, 2015 | Substantially Equivalent |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | Feb 3, 2015 | Substantially Equivalent |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | Nov 2, 2012 | Substantially Equivalent |
| K112513 | EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER | Dec 9, 2011 | Substantially Equivalent |
| K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER | Feb 23, 2011 | Substantially Equivalent |