FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
K Number: K872917
·
Decision Aug 11, 1987
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
64
Review Days
15
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Basic Information
- Device Name
- JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
- K Number
- K872917
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- July 27, 1987
- Decision Date
- August 11, 1987
- Product Code
- BSY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by American Pharmaseal Div. Ahsc
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| 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 |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | Mar 27, 1987 | Substantially Equivalent |