510(k) K172995
- Device
- Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
- Applicant
- Terumo Medical Corporation
- 510(k) number
- K172995
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-21
- Date received
- 2017-09-27
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Liang Lu
- Address
- 950 Elkton Blvd. Elkton MD US 21921 21921
FDA Registration Numbers#
- 3010966701
- 3010055973
- 3010131137
- 3025341484
- 3038966633
- 3006950086
- 9616088
- 3006131984
- 3020968442
- 3008328690
- 1061124
- 3012179728
- 1000393132
- 2648045
- 2017865
- 9610825
- 3010155661
- 3004785273
- 8020616
- 3033589330
- 3032916632
- 2134265
- 3008403546
- 2090040
- 3002807314
- 3011564431
- 2528981
- 2024311
- 3016904853
- 2182208
- 3030447506
- 1721676
- 1424263
- 1055236
- 2248146
- 3022815697
- 3015138222
- 3006425876
- 3003610571
- 2183787
- 3011137372
- 1625685
- 3010419931
- 2024168
- 3016678045
- 3004737415
- 1647149
- 3013288201
- 3008824097
- 3012050423
- 3001374820
- 3014656749
- 3010200163
- 3020347218
- 1649395
- 1123137
- 3010882708
- 3001124136
- 3011024991
- 9611612
- 1056553
- 3008114965
- 3004134316
- 8010026
- 1224960
- 3036802499
- 1722746
- 3007284313
- 2011171
- 3009144177
- 3007695959
- 9616099
- 3009393076
- 2020394
- 3008261722
- 3011623145
- 1016427
- 1000563940
- 3009420598
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025-10-23 |
Legacy Summary#
summary
FDA Review#
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