510(k) K083169
- Device
- EPTFE SLFTM SPIRAL VASCULAR GRAFT
- Applicant
- TAYSIDE FLOW TECHNOLOGIES LIMITED
- 510(k) number
- K083169
- Product code
- DSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-30
- Date received
- 2008-10-27
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- EDWIN LINDSAY
- Address
- 1141 E. Hawken Way Chandler AZ US 85286 85286
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 · openFDA JSON
Legacy Summary
summary
FDA Review
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