Cook Incorporated · Class II · Cleared Jul 28, 2015
| K-number | K142829 |
| Device name | 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 |
| Applicant | Cook Incorporated |
| Product code | DYB |
| Device class | Class II |
| Decision date | Jul 28, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov