SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
FDA 510(k) clearance K883054 · decided 1988-09-26
Clearance details
- K-number
- K883054
- Device name
- SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
- Applicant
- Scimed Life Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-19
- Decision date
- 1988-09-26
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- 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 |
|---|---|---|
| APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264) | Scimed Life Systems, Inc. | 2011-03-31 |
| APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263) | Scimed Life Systems, Inc. | 2010-09-08 |
| MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261) | Scimed Life Systems, Inc. | 2010-09-08 |
| PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260) | Scimed Life Systems, Inc. | 2010-09-01 |
| PTCA CATHETERS (P860019/S259) | Scimed Life Systems, Inc. | 2010-08-13 |
| BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258) | Scimed Life Systems, Inc. | 2010-07-28 |
| MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS (P860019/S256) | Scimed Life Systems, Inc. | 2010-06-23 |
| APEX PTCA DILATATION CATHETER (P860019/S255) | Scimed Life Systems, Inc. | 2010-05-27 |