510(k) K132592 ยท DYB Introducer, Catheter
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 9, 2014 |
| Received | Aug 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2017 | Cook Inc. Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Introducers are intended for introduction of balloons, closed and non-tapered end catheters or Terminated |
DYB | None listed |
| Feb 1, 2017 | Cook Inc. Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Introducers are intended for introduction of balloons, closed and non-tapered end catheters Terminated |
DYB | None listed |
| Feb 1, 2017 | Cook Inc. Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Terminated |
KGZ | None listed |
| Feb 1, 2017 | Cook Inc. Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and intervent Terminated |
DYB | None listed |
| Feb 1, 2017 | Cook Inc. Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Introducers are intended for introduction of balloons, closed and non-tapered Terminated |
DYB | None listed |
| Feb 1, 2017 | Cook Inc. Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Introducers are intended for introduction of balloons, closed and non-tapered end ca Terminated |
DYB | None listed |
| Feb 1, 2017 | Cook Inc. TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood v Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.