510(k) K955588
- Device
- VASCUTEK GRAFT SIZER SET
- Applicant
- CARBOMEDICS, INC.
- 510(k) number
- K955588
- Product code
- DSY
- Decision
- Se Subject To Tracking Reg (ST)
- Decision date
- 1996-03-07
- Date received
- 1995-12-07
- Regulation
- 870.3450
- Classification name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- EDWARD E NEWTON
- Address
- 1300 E. Anderson Ln. Austin TX US 78752 78752
FDA Registration Numbers
- 1018233
- 3013718163
- 2242352
- 1720929
- 3012536737
- 3010097171
- 9612515
- 3007676031
- 1640201
- 3010407203
- 3015225571
- 3006082230
- 1220477
- 3011175548
- 2020394
- 3015309643
- 2246552
- 1723241
- 1220948
- 1721504
- 1721676
- 1724474
- 3033589330
- 3006950086
- 3010162973
- 2017233
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05037881038902 | Graft Sizer Set | VASCUTEK LTD | 2016-09-21 |
Legacy Summary
summary
FDA Review
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