510(k) K082324
- Device
- TRUFILL DCS SYRINGE
- Applicant
- Cordis Neurovascular, Inc.
- 510(k) number
- K082324
- Product code
- HCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-12
- Date received
- 2008-08-14
- Regulation
- 882.5950
- Classification name
- Device, Neurovascular Embolization
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Amarilys Machado
- Address
- 14201 NW 60th Ave. Miami Lakes FL US 33014 33014
FDA Registration Numbers
- 9615728
- 1226348
- 9617601
- 3002124543
- 3008264254
- 2134265
- 3000143502
- 3010173425
- 2029275
- 2022435
- 3013353964
- 3010178296
- 9616684
- 1220477
- 3015309643
- 3003524171
- 9614654
- 3016245399
- 3006950086
- 2030598
- 3031550970
- 3033589330
- 2124215
- 3008307705
- 3014644549
- 3002807295
- 3015550451
- 3016609702
- 3014162263
- 3007029079
- 3015531723
- 1721676
- 3007628272
- 3010079067
- 3005168196
- 3007738736
- 3013758550
- 3016591327
- 2029214
- 3015453963
- 3009380063
- 3008114965
- 2011171
- 3027595249
- 1820334
- 3008837339
- 3009761573
- 3012543881
- 3013944123
- 3017961114
- 2126666
- 3012536737
- 1043729
- 3008881809
- 3008824097
- 3015615738
- 3008853977
- 3016540856
- 3012931345
- 2133641
- 3013556777
- 1225687
Source Documents
510(k) summary PDF not indicated by FDA
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