# K142829: 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 Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 28, 2015 after 301 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 26 (21 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924607 (1993). 6 ancestors in all.
13 later devices descend from it; 3 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 5.
- K984500: Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1998) Summary page 5.

## Most influential descendants
- K152913: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (2016), 6 descendants of its own
- K171820: Transjugular Liver Access Sets (2018), 5 descendants of its own
- K152225: Edwards eSheath Introducer Set (2015), 4 descendants of its own
- K162184: Edwards eSheath Introducer Set (2016), 3 descendants of its own
- K200258: Edwards eSheath Introducer Set (2020), 2 descendants of its own

## Recalls of this device
- Nov 26, 2025 · Class II · Z-0993-2026: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly t
- Nov 12, 2021 · Class II · Z-0387-2022: Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
- Nov 12, 2021 · Class II · Z-0388-2022: Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
- Sep 28, 2021 · Class II · Z-0185-2022: Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the dev
- Sep 28, 2021 · Class II · Z-0186-2022: Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the dev
- Nov 24, 2020 · Class I · Z-0592-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0607-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0609-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0594-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0597-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0599-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0601-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0602-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0603-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0604-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0605-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0606-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0610-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0591-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0593-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0596-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0598-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0600-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0595-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0608-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver
- Nov 24, 2020 · Class I · Z-0611-2021: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adver

## Indications for use
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Source page: https://510kreport.com/device/K142829
Methodology: https://510kreport.com/methodology