510(k) K895268
- Device
- ARROW HANDS-OFF THERMO-PACE
- Applicant
- ARROW INTL., INC.
- 510(k) number
- K895268
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-06
- Date received
- 1989-08-23
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS D NICKEL
- Address
- P.O. Box 6306 Hill And George Ave.S Reading PA US 19610 19610
FDA Registration Numbers#
- 3026788751
- 3015225571
- 3004467263
- 3030714660
- 3007628272
- 3013656790
- 3012159165
- 3013557562
- 3029973819
- 3008307705
- 1061124
- 1060680
- 1820334
- 3009888344
- 3004122598
- 3005012805
- 3009291251
- 3012494290
- 3012279212
- 1319639
- 3003610571
- 9615817
- 3005770916
- 3004737415
- 1220452
- 3012931345
- 2029214
- 2124215
- 1317547
- 3004519921
- 1035166
- 9612126
- 3007830707
- 9710602
- 9616088
- 1061927
- 1721686
- 3012050423
- 3011050534
- 1220477
- 3008853977
- 3003678543
- 9616683
- 1318694
- 2528981
- 3011237770
- 2024311
- 1018233
- 3005941719
- 3004365956
- 1058584
- 3017262662
- 3002808467
- 1423395
- 9617594
- 1000523114
- 3011137372
- 3009746061
- 3012766489
- 2032098
- 3014499739
- 9611665
- 1043214
- 1423537
- 3006950086
- 2518902
- 9617601
- 3007361214
- 3006131984
- 3015550451
- 8043983
- 3033589330
- 3007289408
- 9616099
- 2134812
- 3007836437
- 3006425876
- 3006985147
- 2183744
- 3042190142
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQO #
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