FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PENNINE SUCTION CATHETERS
K Number: K852080
·
Decision Jun 3, 1985
Classifications
1
FEI Numbers
257
Registration Numbers
257
Same Product Code
115
Applicant Total
8
Review Days
21
Basic Information
- Device Name
- PENNINE SUCTION CATHETERS
- K Number
- K852080
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- PENNINE MEDICAL LTD.
- Date Received
- May 13, 1985
- Decision Date
- June 3, 1985
- 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 PENNINE MEDICAL LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | Jan 8, 1986 | Substantially Equivalent |
| K852859 | PENNINE CONNECTING TUBING | Jul 30, 1985 | Substantially Equivalent |
| K852081 | PENNINE OXYGEN LINK TUBING | Jun 14, 1985 | Substantially Equivalent |
| K844874 | PENNINE LINK YANKAUERS | Jun 6, 1985 | Substantially Equivalent |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | Jun 5, 1985 | Substantially Equivalent |
| K852079 | PENNINE DERBY YANKAUER | Jun 3, 1985 | Substantially Equivalent |
| K844873 | PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 | Feb 21, 1985 | Substantially Equivalent |