510(k) K140420
- Device
- VADO STEERABLE SHEATH
- Applicant
- KALILA MEDICAL, INC.
- 510(k) number
- K140420
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-01
- Date received
- 2014-02-18
- 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
- CARRIE NEUBERGER
- Address
- 745 Camden Ave., Suite A Campbell CA US 95008 95008
FDA Registration Numbers#
- 2648045
- 3010882708
- 3027366703
- 3000268902
- 9616088
- 3030446844
- 2953200
- 1313046
- 3020954746
- 2527072
- 3025341484
- 2030404
- 1650907
- 1835568
- 3004737415
- 1000523114
- 3008328690
- 3008514120
- 2029015
- 3013400708
- 3019807891
- 9616683
- 3007695959
- 3009605245
- 9617592
- 1061124
- 1055236
- 3006425876
- 2090040
- 3031571797
- 2017865
- 3017689643
- 3005334138
- 1035166
- 3035111606
- 2134812
- 2024168
- 1722746
- 3045178474
- 3017060084
- 3008114965
- 3016591327
- 3004111573
- 2030598
- 3011137372
- 3033589330
- 2953359
- 1526863
- 3013764800
- 9611612
- 3006260740
- 2246552
- 3001124136
- 3030574705
- 3007697249
- 1625425
- 9680794
- 8010026
- 3008403546
- 3020347218
- 3005168196
- 3011024991
- 3004091615
- 2523676
- 1319211
- 9610825
- 3008998256
- 3011237770
- 2939561
- 1921846
- 3021951050
- 3048101437
- 9710641
- 3010131137
- 2020394
- 3008307705
- 3016678045
- 2025816
- 3010155661
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262674 | Giranel Guiding Sheath Set | Kossel Medtech (Suzhou) Co., Ltd. | 2026-10-15 |
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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