510(k) K160254
- Device
- GORE DrySeal Flex Introducer Sheath
- Applicant
- W.L. GORE & ASSOCIATES, INC.
- 510(k) number
- K160254
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-12
- Date received
- 2016-02-01
- 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
- Mary Townsend
- Address
- 1505 N Fourth St. Flagstaff AZ US 86004 86004
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3004134316
- 3031983053
- 3043337628
- 3007697249
- 2521402
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- 3020954746
- 3012050423
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132658954 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659050 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659043 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659036 | GORE | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659029 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659012 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659005 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658992 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658985 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658978 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658961 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132659067 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658947 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658930 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658923 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658916 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658909 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658893 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658879 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2024-12-02 |
| 00733132629985 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2023-05-25 |
| 00733132628285 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628308 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628322 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628346 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-07-11 |
| 00733132628094 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
| 00733132628261 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
| 00733132629978 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | 2020-01-09 |
Legacy Summary
summary
FDA Review
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