FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHETER, IRRIGATION
K Number: K770706
·
Decision May 6, 1977
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
76
Applicant Total
92
Review Days
18
Basic Information
- Device Name
- CATHETER, IRRIGATION
- K Number
- K770706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- MALLINCKRODT CRITICAL CARE
- Date Received
- April 18, 1977
- Decision Date
- May 6, 1977
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBX), ordered by most recent decision date.
MOERAE VEIN PREPARATION KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRAFTSAVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MISONIX IRRIGATION SYSTEM MOEDL BC20P
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by MALLINCKRODT CRITICAL CARE
| K Number | Device Name | ||
|---|---|---|---|
| K880343 | BURNEY GALLBLADDER CATHETER KIT | May 1, 1989 | Substantially Equivalent |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Feb 2, 1988 | Substantially Equivalent |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | Jan 29, 1988 | Substantially Equivalent |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | Jan 6, 1988 | Substantially Equivalent |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | Nov 6, 1987 | Substantially Equivalent |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | Nov 6, 1987 | Substantially Equivalent |
| K873833 | THERMOCOUPLE ADAPTER | Nov 3, 1987 | Substantially Equivalent |
| K873004 | GUIDING CATHETER | Sep 15, 1987 | Substantially Equivalent |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | Apr 21, 1987 | Substantially Equivalent |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | Aug 1, 1986 | Substantially Equivalent |