510(k) K152044
- Device
- Flexor Radial Hydrophilic Introducer Access Set
- Applicant
- COOK INCORPORATED
- 510(k) number
- K152044
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-14
- Date received
- 2015-07-23
- 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
- SARAH REEVES
- Address
- 750 Daniels Way P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers#
- 3013758550
- 3037050339
- 3010421104
- 1000563940
- 1035166
- 9616088
- 3030236028
- 1016427
- 3006131984
- 1061927
- 1018470
- 1118880
- 3009211636
- 3003898360
- 3020283264
- 3017298588
- 3016678045
- 3017636737
- 2527072
- 2124215
- 3008514120
- 3010665433
- 3010432890
- 2024168
- 2246552
- 3006283319
- 3015309643
- 2011171
- 3030733800
- 3008998256
- 2183744
- 3045178474
- 1000121056
- 2183787
- 3011657089
- 3008361782
- 3017567825
- 9610825
- 3010882708
- 3013557562
- 3020968442
- 2939561
- 3011752740
- 2020394
- 1054241
- 3002808467
- 2528981
- 2320762
- 2134244
- 8043892
- 1018233
- 3030446844
- 3011642792
- 2015691
- 3008011247
- 3010041511
- 3015173212
- 2182208
- 3014656749
- 1064858
- 3004785273
- 3003637635
- 1423537
- 3035111606
- 3015225571
- 3041276591
- 3008328690
- 1828424
- 2523676
- 9710641
- 9617465
- 9612164
- 3017060084
- 3015859709
- 3004091615
- 3011063223
- 1318694
- 1928237
- 3008452825
- 1055236
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
Legacy Summary#
summary
FDA Review#
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