FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHILEY PERFUSION TUBING SETS
K Number: K920594
·
Decision Mar 18, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
174
Review Days
401
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Basic Information
- Device Name
- SHILEY PERFUSION TUBING SETS
- K Number
- K920594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shiley, Inc.
- Date Received
- February 11, 1992
- Decision Date
- March 18, 1993
- Product Code
- DTM
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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Other Clearances by Shiley, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910991 | SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM | Nov 27, 1991 | Substantially Equivalent |
| K911876 | SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 | Aug 9, 1991 | Substantially Equivalent |
| K910923 | BCD ADVANCED | Apr 9, 1991 | Substantially Equivalent |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | Jan 14, 1991 | Substantially Equivalent |
| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | Oct 2, 1990 | Substantially Equivalent |
| K901624 | SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. | Jul 3, 1990 | Substantially Equivalent |
| K901250 | PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
| K901249 | PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR | Jun 11, 1990 | Substantially Equivalent |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | May 10, 1990 | Substantially Equivalent |
| K900548 | SHILEY PHONATION VALVE | Apr 23, 1990 | Substantially Equivalent |