Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2017 | Kalila Medical Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, Terminated |
DYB | K160721 |
| Oct 26, 2017 | Arrow International Inc Arterial Access Tray, introducer catheter; Model: GU-04020 Terminated |
DYB | K780532 |
| Sep 12, 2017 | Terumo Medical Corporation Destination Guiding Sheath catheter introducer, Catalog Number: RSR06
Product Usage:
The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic device Terminated |
DYB | K012584 |
| Jun 27, 2017 | Arrow International Inc Arrow Glide Thru Peel-Away Sheath/Dilator Introducer Terminated |
DYB | K122854 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| 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 | K142183 |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300 Terminated |
DYB | K131079 |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400 Terminated |
DYB | K131079 |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100 Terminated |
DYB | K131079 |
| May 22, 2017 | Creganna Medical Devices Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200 Terminated |
DYB | K131079 |
| May 9, 2017 | Arrow International Inc 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter
2) Arrow PSI Kit Terminated |
DYB | K780532 |
| May 4, 2017 | Terumo Medical Corporation Destination Renal Guiding Sheath
Intended for the introduction of interventional and diagnostic devices into the human vasculature. Terminated |
DYB | K012854 |
| Mar 24, 2017 | Merit Medical Systems, Inc. 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT.
Produc Usage:
The Merit Prelude Short Sheath Introducer is intended to provide access and facili Terminated |
DYB | K082063 |
| Feb 15, 2017 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve).
The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter Terminated |
DYB | K130559 |
| 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 | K132592 |
| 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 | K132592 |
| 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 | K132592 |
| 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 | K132592 |
| 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 | K132592 |
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 10 cm 5 pack
Product Code: HAL510F
Product Usage:
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo Terminated |
DYB | K161183 |
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 90 cm
Product Code: HAL590
Product Usage:
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Th Terminated |
DYB | K161183 |
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 45 cm
Product Code: HAL545
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Terminated |
DYB | K161183 |
| Jan 5, 2017 | Merit Medical Systems, Inc. PreludeEASE Hydrophilic Sheath Introducer Dilator
The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into Terminated |
DYB | K140543 |
| Nov 18, 2016 | Greatbatch Medical Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.
The radiopaque Stiffer Coaxial Micro-Introd Terminated |
DYB | K071574 |
| Nov 11, 2016 | Greatbatch Medical ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 Terminated |
DYB | K072248 |
| Oct 7, 2016 | Argon Medical Devices, Inc MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.
A sheath used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | K071574 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
C55 S61CM D66CM GLOBALCatalog # 990061-055-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
C90 S61CM D66CM GLOBAL Catalog # 990061-090-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
C90 S79CM D84CM GLOBAL Catalog # 990079-090-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
C70 S79CM D84CM GLOBAL Catalog # 990079-070-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F
C55 S79CM D84CM GLOBAL Catalog # 990079-055-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog # 990061-120-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the le Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S61CM D66CM GLOBAL Catalog # 990061-070-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the l Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated |
DYB | K101497 K122958 |
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