FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
K Number: K001966
·
Decision Jul 20, 2000
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
51
Review Days
22
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Basic Information
- Device Name
- REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
- K Number
- K001966
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics, Inc.
- Date Received
- June 28, 2000
- Decision Date
- July 20, 2000
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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| K051990 | ECHELON MICRO CATHETER | Jan 4, 2006 | Substantially Equivalent |
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