FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUAL PURPOSE CLOSED CATHETER
K Number: K982945
·
Decision Sep 22, 1998
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
1
Review Days
32
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Basic Information
- Device Name
- DUAL PURPOSE CLOSED CATHETER
- K Number
- K982945
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spirit Medical Systems, Inc.
- Date Received
- August 21, 1998
- Decision Date
- September 22, 1998
- 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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