FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHILEY MULTIPRO CATHETER
K Number: K832044
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
73
Applicant Total
174
Review Days
97
Basic Information
- Device Name
- SHILEY MULTIPRO CATHETER
- K Number
- K832044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- SHILEY, INC.
- Date Received
- June 24, 1983
- Decision Date
- September 29, 1983
- Product Code
- DXE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | Oct 2, 1990 | Substantially Equivalent |
| K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. | Jul 3, 1990 | Substantially Equivalent |
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| K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | May 10, 1990 | Substantially Equivalent |