Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
FDA 510(k) clearance K232013 · decided 2024-03-28
Clearance details
- K-number
- K232013
- Device name
- Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
- Applicant
- Goodman Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-06
- Decision date
- 2024-03-28
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- PNO
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nagoya, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S003) | Goodman Co., Ltd. | 2026-07-22 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S005) | Goodman Co., Ltd. | 2026-07-22 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S004) | Goodman Co., Ltd. | 2026-07-22 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S001) | Goodman Co., Ltd. | 2024-08-02 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026) | Goodman Co., Ltd. | 2024-06-06 |