510(k) K230283
- Device
- Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 4054
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K230283
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-01
- Date received
- 2023-02-01
- 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
- Chidalu Mozie
- Address
- 15900 Valley View Ct. Sylmar CA US 91342 91342
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 |