FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRIGATION CATHETER
K Number: K780788
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
174
Review Days
38
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Basic Information
- Device Name
- IRRIGATION CATHETER
- K Number
- K780788
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Shiley, Inc.
- Date Received
- May 15, 1978
- Decision Date
- June 22, 1978
- Product Code
- GBX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Shiley, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920594 | SHILEY PERFUSION TUBING SETS | Mar 18, 1993 | Substantially Equivalent |
| 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 |