510(k) K142183 ยท DYB Introducer, Catheter
GLIDESHEATH SLENDER
| Applicant | Terumo Medical Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Nov 21, 2014 |
| Received | Aug 8, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.