510(k) K070417
- Device
- ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
- Applicant
- ST. JUDE MEDICAL
- 510(k) number
- K070417
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-05
- Date received
- 2007-02-12
- 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
- Laura Moen-Ftacek
- Address
- 14901 Deveau Pl. Minnetonka MN US 55345 55345
FDA Registration Numbers#
- 1123137
- 2527072
- 3021951050
- 3009211636
- 3032916632
- 2953200
- 3008452825
- 3030447506
- 3013400708
- 2183870
- 1018233
- 2134265
- 9680794
- 3002648230
- 1835568
- 3043337628
- 3004091615
- 3007882731
- 1526711
- 3005580113
- 3031571797
- 1625425
- 2011171
- 2248146
- 1061124
- 3008002401
- 3012307300
- 3020283264
- 1225698
- 3011610434
- 3010041511
- 3010391198
- 3013986346
- 3006131984
- 2182269
- 3013162291
- 3010432890
- 3022815697
- 3016986313
- 3010131137
- 9610847
- 3009420598
- 3015859709
- 3015173212
- 3012536737
- 3004111573
- 1650907
- 1000121056
- 2939561
- 3015453963
- 3015138222
- 3008824097
- 3009905888
- 1318694
- 2030624
- 2024168
- 3031823122
- 3013300026
- 1724474
- 3015615738
- 3025341484
- 3011752740
- 3004519921
- 3010055973
- 3013764800
- 3033589330
- 2015691
- 8010026
- 9617465
- 3010220595
- 1417485
- 3001124136
- 1064858
- 2245270
- 2320762
- 1054241
- 3027815
- 3007830707
- 2124215
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 |
Legacy Summary#
summary
FDA Review#
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