STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED
FDA 510(k) clearance K905839 · decided 1991-04-19
Clearance details
- K-number
- K905839
- Device name
- STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED
- Applicant
- Strato Medical Corp.
- Decision
- Unknown
- Date received
- 1990-12-27
- Decision date
- 1991-04-19
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. recall (Z-0405-2011) | Angiodynamics, INC | 2010-11-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CRYOMAX(TM) (P820002/S002) | Strato Medical Corp. | 1983-08-03 |
| CRYOMAX(TM) (P820002/S001) | Strato Medical Corp. | 1983-04-26 |
| CRYOMAX(TM) (P820002) | Strato Medical Corp. | 1983-01-31 |