COOK MBC PTCA BALLOON DILATATION CATHETER
FDA premarket approval P990008 · decided 1999-09-27
Approval details
- PMA number
- P990008
- Trade name
- COOK MBC PTCA BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Cook, Inc.
- Date received
- 1999-02-11
- Decision date
- 1999-09-27
- Days to decision
- 228 days
- Decision code
- APWD
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (K133130) | Cook, Inc. | 2015-01-09 |
| ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (K140593) | Cook, Inc. | 2014-12-15 |
| FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592) | Cook, Inc. | 2014-10-09 |
| CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY (K133597) | Cook, Inc. | 2014-04-18 |
| CANTATA(R) 2.9 MICROCATHETER (K131772) | Cook, Inc. | 2014-02-20 |
| ADVANCE CS CORONARY SINUS INFUSION CATHETER (K131204) | Cook, Inc. | 2014-01-29 |
| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
| ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020) | Cook, Inc. | 2013-10-25 |