510(k) K013577
- Device
- ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
- Applicant
- Atrium Medical Corp.
- 510(k) number
- K013577
- Product code
- DSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-25
- Date received
- 2001-10-29
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JOSEPH P PAOLO
- Address
- 5 Wentworth Dr. Hudson NH US 03051 03051
FDA Registration Numbers#
- 1721676
- 1018233
- 3010407203
- 1220948
- 3013718163
- 3010097171
- 3015309643
- 2020394
- 9612515
- 2017233
- 2242352
- 3010162973
- 3012536737
- 1220477
- 2246552
- 3006082230
- 1724474
- 1640201
- 1720929
- 3033589330
- 3011175548
- 3015225571
- 1723241
- 1721504
- 3007676031
- 3006950086
Source Documents#
510(k) summary PDF not indicated by FDA
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| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | 2020-12-11 |