510(k) K213638
- Device
- Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
- Applicant
- Argon Medical Devices
- 510(k) number
- K213638
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-10
- Date received
- 2021-11-18
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ana Jimenez-Hughes
- Address
- 1445 Flat Creek Rd. Athens TX US 75751 75751
FDA Registration Numbers#
- 1526863
- 1282497
- 2523676
- 1422634
- 3008824097
- 2939561
- 3037047821
- 3009605245
- 3033589330
- 3030236028
- 2024311
- 3015970743
- 3008261722
- 9612164
- 1710034
- 1450662
- 9610825
- 3008328690
- 3013400708
- 9616666
- 3008853977
- 2032112
- 3030574705
- 3011623145
- 1820334
- 3008307705
- 2134265
- 3010220595
- 3030733800
- 3008002401
- 3007830707
- 3007695959
- 1721686
- 3007882731
- 3010419931
- 3003610571
- 1123137
- 3012050423
- 3015615738
- 3001124136
- 3016904853
- 3007697249
- 9617465
- 3012179728
- 3043337628
- 1048735
- 1721676
- 8043892
- 3013162291
- 3005168196
- 3013288201
- 1313046
- 1650907
- 1000121056
- 9673241
- 1000393132
- 3020283264
- 3002807314
- 3010391198
- 3006950086
- 3030447506
- 3012307300
- 1647149
- 3010200163
- 1056553
- 2090040
- 3005232773
- 2024168
- 3011642792
- 3014687026
- 3012536737
- 3009144177
- 3008514120
- 1000523114
- 3005580113
- 1054241
- 3009888344
- 3020954746
- 3010155661
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases