FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPRING-WOUND EPIDURAL CATHETER
K Number: K991879
·
Decision Oct 28, 1999
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
8
Review Days
148
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Basic Information
- Device Name
- SPRING-WOUND EPIDURAL CATHETER
- K Number
- K991879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micor, Inc.
- Date Received
- June 2, 1999
- Decision Date
- October 28, 1999
- Product Code
- BSO
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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Other Clearances by Micor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031600 | CONDUCTION CATHETER | Aug 13, 2003 | Substantially Equivalent |
| K003966 | WUNDCATH CONDUCTION CATHETER | Jul 17, 2001 | Substantially Equivalent |
| K001717 | MICOR CONDUCTION CATHETER | Sep 20, 2000 | Substantially Equivalent |
| K001940 | MICOR ANESTHESIA CONDUCTION KIT | Aug 11, 2000 | Substantially Equivalent |
| K861008 | PERCUTANEOUS CATHETERS | Apr 29, 1986 | Substantially Equivalent |
| K860339 | PERCUTANEOUS CATHETERS | Mar 31, 1986 | Substantially Equivalent |
| K854018 | ANGIOGRAPHY CATHETERS | Jan 16, 1986 | Substantially Equivalent |