BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145— 510(k) K014075
Substantially EquivalentBaylis Medical Co., Inc.
FDA 510(k) clearance K014075 for BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145, Substantially Equivalent on 2002-03-07. Applicant: Baylis Medical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Baylis Medical Co., Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, Ontario, CA
Recent devices under product code DQX
view allMore clearances from Baylis Medical Co., Inc.
view allAdverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K014075
K-number listed on FDA's recall record- Z-0356-2016 — ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
- Z-1442-2015 — ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014075.
Data sourced from openFDA. This site is unofficial and independent of the FDA.