INOUE-BALLOON Catheter
FDA premarket approval P910054/S008 · decided 2021-08-31
Approval details
- PMA number
- P910054
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INOUE-BALLOON Catheter
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Applicant
- Toray Industries (America), Inc.
- Date received
- 2021-08-13
- Decision date
- 2021-08-31
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New York, NY
- Statement
- Change to the location of the supplier of latex tube components.
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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 |