FDA 510(k)
Substantially Equivalent
🇺🇸 United States
AMERICAN PHARMASEAL I.V. START KIT
K Number: K842860
·
Decision Aug 30, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
64
Review Days
38
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Basic Information
- Device Name
- AMERICAN PHARMASEAL I.V. START KIT
- K Number
- K842860
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- July 23, 1984
- Decision Date
- August 30, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by American Pharmaseal Div. Ahsc
| K Number | Device Name | ||
|---|---|---|---|
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | Dec 30, 1987 | Substantially Equivalent |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | Dec 3, 1987 | Substantially Equivalent |
| K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE | Nov 6, 1987 | Substantially Equivalent |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | Aug 11, 1987 | Substantially Equivalent |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | Aug 10, 1987 | Substantially Equivalent |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | May 8, 1987 | Substantially Equivalent |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | Apr 1, 1987 | Substantially Equivalent |