510(k) K152913
- Device
- GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
- Applicant
- CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
- 510(k) number
- K152913
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-21
- Date received
- 2015-10-02
- 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
- ORLA HICKEY
- Address
- Parkmore W. Galway IE
FDA Registration Numbers#
- 3004784537
- 3013557562
- 3014272734
- 3006425876
- 3011752740
- 2953200
- 9710641
- 1319211
- 3010131137
- 3013162291
- 3010291427
- 8010026
- 3038966633
- 3033589330
- 3015615738
- 2134265
- 1319639
- 2182269
- 3013986346
- 2032112
- 2182208
- 3011024991
- 3010055973
- 1000121056
- 1118880
- 1220477
- 3037047821
- 3011657089
- 3009437315
- 1054241
- 3005334138
- 3001374820
- 3013758550
- 1721686
- 3010882708
- 3021951050
- 3015225571
- 2953359
- 9616666
- 1056553
- 9680794
- 3010200163
- 3009746061
- 3013400708
- 1722746
- 3005580113
- 8043892
- 1417485
- 2245270
- 3020954746
- 3035111606
- 9610847
- 3030236028
- 3006260740
- 1644312
- 1724474
- 3002807314
- 2090040
- 3009144177
- 3011642792
- 2015691
- 3005168196
- 3011564431
- 9681477
- 9616088
- 3001124136
- 2246552
- 2320762
- 3043337628
- 2025816
- 1018470
- 3005994106
- 2183870
- 9617592
- 1000523114
- 1647149
- 2648045
- 9611612
- 3003610571
- 3010419931
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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