510(k) K984526
- Device
- ACUSEAL CARDIOVASCULAR PATCH
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K984526
- Product code
- DXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-08
- Date received
- 1998-12-21
- Regulation
- 870.3470
- Classification name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- 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
- TIMOTHY J RYNN
- Address
- 3450 W. Kiltie Ln. Flagstaff AZ US 86002 86002
FDA Registration Numbers
- 2024024
- 1450662
- 1018233
- 1060680
- 1282497
- 1416980
- 1649139
- 2648650
- 3003639970
- 3019716369
- 2015691
- 3010041511
- 1043214
- 9680759
- 3009672666
- 3010097171
- 1054241
- 2320762
- 1055236
- 1018470
- 3005381997
- 3007791599
- 1614993
- 3005636544
- 9612515
- 9612501
- 3005064037
- 1835959
- 1526611
- 1647149
- 1640201
- 3010407203
- 3041851334
- 3006638824
- 3006082230
- 1047843
- 3006017180
- 3017102971
- 2020394
- 3011137372
- 3004681519
- 3004365956
- 1221601
- 3007284313
- 3002924436
- 1220948
- 1000393132
- 3031160994
- 2183620
- 3018094310
- 3010452421
- 2210968
- 3010162973
- 3002719998
- 1063481
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132600946 | GORE ACUSEAL Cardiovascular Patch Cardiac | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132600939 | GORE ACUSEAL Cardiovascular Patch Cardiac | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132600922 | GORE ACUSEAL Cardiovascular Patch Cardiac | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132600915 | GORE ACUSEAL Cardiovascular Patch Vascular | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132600908 | GORE ACUSEAL Cardiovascular Patch Vascular | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132600892 | GORE ACUSEAL Cardiovascular Patch Vascular | W. L. Gore & Associates, Inc. | 2016-03-07 |
Legacy Summary
summary
FDA Review
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