510(k) K121234
- Device
- GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- 510(k) number
- K121234
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-20
- Date received
- 2012-04-24
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- ALICIA L HEMPHILL
- Address
- 3450 Kiltie Ln. P.O. Box 2400 Flagstaff AZ US 86003 86003
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3004134316
- 3031983053
- 3043337628
- 3007697249
- 2521402
- 3014687026
- 2248146
- 1423507
- 3022815697
- 3007603855
- 9617592
- 1061124
- 3009350690
- 3025028711
- 3011657089
- 3008307705
- 3017406698
- 3006131984
- 2183870
- 3011564431
- 9617465
- 3038188187
- 3037047821
- 3015453963
- 3008002401
- 3010291427
- 2183744
- 3012536737
- 3006260740
- 1644312
- 2134265
- 3009437315
- 1018470
- 1225698
- 3002648230
- 3011024991
- 3017060084
- 3022518300
- 3010055973
- 1318694
- 3031571797
- 3016591327
- 3030447506
- 3001124136
- 3013557562
- 9616099
- 2024168
- 2246552
- 3010131137
- 3007284313
- 3010141307
- 3001374820
- 1225687
- 1423537
- 1721676
- 1221019
- 1820334
- 2939561
- 2017865
- 3036802499
- 3006425876
- 3006950086
- 3012307300
- 3033589330
- 1220648
- 3013162291
- 3025341484
- 1824619
- 1064858
- 3003915875
- 3017636737
- 3002807314
- 9611612
- 1018233
- 3008403546
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132620005 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619993 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619986 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619979 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619962 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619955 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619948 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132619931 | GORE DRYSEAL Sheath | W. L. Gore & Associates, Inc. | 2017-02-13 |
Legacy Summary
summary
FDA Review
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