FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATOFUSE PCA INFUSER
K Number: K905696
·
Decision Mar 8, 1991
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
45
Review Days
77
Basic Information
- Device Name
- STRATOFUSE PCA INFUSER
- K Number
- K905696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- STRATO MEDICAL CORP.
- Date Received
- December 21, 1990
- Decision Date
- March 8, 1991
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by STRATO MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K945956 | STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS | Jun 6, 1995 | Substantially Equivalent |
| K946250 | STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS | May 2, 1995 | Unknown |
| K942848 | STRATO MEDICAL LIFEPORT LPS 7515 | Feb 1, 1995 | Substantially Equivalent |
| K934518 | STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM | Jan 27, 1995 | Unknown |
| K932509 | STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT | Jan 7, 1994 | Substantially Equivalent |
| K933884 | STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM | Dec 30, 1993 | Unknown |
| K924851 | STRATO MEDICAL SINGLE LUMEN VALVED CATHETER | Dec 13, 1993 | Unknown |
| K924677 | STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH | Jul 30, 1993 | Unknown |
| K921751 | INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER | Jul 7, 1993 | Unknown |
| K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 | Jul 7, 1993 | Unknown |