FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS CATHETERS
K Number: K860339
·
Decision Mar 31, 1986
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
8
Review Days
61
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Basic Information
- Device Name
- PERCUTANEOUS CATHETERS
- K Number
- K860339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Micor, Inc.
- Date Received
- January 29, 1986
- Decision Date
- March 31, 1986
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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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 |
| K991879 | SPRING-WOUND EPIDURAL CATHETER | Oct 28, 1999 | Substantially Equivalent |
| K861008 | PERCUTANEOUS CATHETERS | Apr 29, 1986 | Substantially Equivalent |
| K854018 | ANGIOGRAPHY CATHETERS | Jan 16, 1986 | Substantially Equivalent |