DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
FDA 510(k) clearance K063525 · decided 2007-01-05
Clearance details
- K-number
- K063525
- Device name
- DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-01-05
- Days to decision
- 44 days
- Clearance type
- Special
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Datascope Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014) | Datascope Corp. | 1994-12-22 |
| HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010) | Datascope Corp. | 1992-11-16 |
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013) | Datascope Corp. | 1992-08-26 |
| HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011) | Datascope Corp. | 1991-10-04 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009) | Datascope Corp. | 1990-09-28 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005) | Datascope Corp. | 1989-05-17 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008) | Datascope Corp. | 1989-03-09 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006) | Datascope Corp. | 1988-09-09 |