FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K Number: K870704
·
Decision Mar 27, 1987
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
64
Review Days
35
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Basic Information
- Device Name
- CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
- K Number
- K870704
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- February 20, 1987
- Decision Date
- March 27, 1987
- 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 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 |