INOUE BALLOON CATHETER
FDA premarket approval P910054/S002 · decided 2002-02-13
Approval details
- PMA number
- P910054
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INOUE BALLOON CATHETER
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Applicant
- Toray Industries (America), Inc.
- Date received
- 2001-05-21
- Decision date
- 2002-02-13
- Days to decision
- 268 days
- Decision code
- APPR
- Product code
- MAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INOUE BALLOON CATHETER WHICH IS INDICATED FOR PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY IN PATIENTS WITH HEMODYNAMICALLY SIGNIFICANT MITRAL VALVULAR STENOSIS RESULTING PRIMARILY FROM COMMISSURAL FUSION OF THE MITRAL VALVE CUSPS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TORAYGUIDE GUIDEWIRE (K042370) | Toray Industries (America), Inc. | 2004-12-17 |
| TORAYSULFONE DIALYZER, BS-L SERIES (K030050) | Toray Industries (America), Inc. | 2003-09-29 |
| TORAYSULFONE DIALYZER (K002512) | Toray Industries (America), Inc. | 2001-10-15 |
| HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (K994198) | Toray Industries (America), Inc. | 2000-08-25 |
| FILTRYZER (K942681) | Toray Industries (America), Inc. | 1995-06-22 |
| FILTRYZER(TM) (K935471) | Toray Industries (America), Inc. | 1995-05-19 |
| FILTRYZER (K940910) | Toray Industries (America), Inc. | 1995-05-04 |
| TORAY FILTRYZER DIALYZERS (K884339) | Toray Industries (America), Inc. | 1989-03-17 |