510(k) K142829 ยท DYB Introducer, Catheter
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 28, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Cook Incorporated Flexor Check-Flo Introducers and Sets, Reference Part Numbers:
1) KCFW-9.0-18/38-45-RB-ANL0-HC;
2) KCFW-9.0-18/38-45-RB-ANL1-HC;
3) KCFW-10.0-35-45-RB-HFANL0-HC;
4) KCFW-10.0-35-45-RB-HFANL1-HC; Open, Classified |
DYB | None listed |
| Nov 12, 2021 | Cook Inc. Flexor Check-Flo Introducer Ansel Modification
Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC
Order Number/GPN: G44154
Intended to introduce therapeutic or diagnostic devices into the vasculature, excl Terminated |
DYB | None listed |
| Nov 12, 2021 | Cook Inc. Flexor Check-Flo Introducer Ansel Modification
Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC
Order Number/GPN: G44155
Intended to introduce therapeutic or diagnostic devices into the vasculature, exclu Terminated |
DYB | None listed |
| Sep 28, 2021 | Cook Inc. Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908
The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dila Terminated |
DYB | None listed |
| Sep 28, 2021 | Cook Inc. Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069
The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagn Terminated |
DYB | None listed |
| Dec 23, 2020 | Cook Inc. Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagn Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.