BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
FDA 510(k) clearance K014075 · decided 2002-03-07
Clearance details
- K-number
- K014075
- Device name
- BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-11
- Decision date
- 2002-03-07
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use de recall (Z-0356-2016) | Baylis Medical Corp * | 2015-12-01 |
| ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use recall (Z-1442-2015) | Baylis Medical Corp * | 2015-04-13 |