510(k) K024126
- Device
- CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
- Applicant
- Abbott Laboratories
- 510(k) number
- K024126
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-14
- Date received
- 2002-12-16
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- NICOHL R WILDING
- Address
- 200 Abbott Park Rd. D-389, Bldg. J-45 Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 1123137
- 9615817
- 3032916632
- 3008497357
- 3030447506
- 3003678543
- 1018233
- 3021343210
- 2134265
- 3005595283
- 9680794
- 3031571797
- 3004091615
- 3042190142
- 1060680
- 3007361214
- 2011171
- 3012279212
- 1625425
- 1061124
- 8043817
- 3012307300
- 3010041511
- 3006131984
- 3003594449
- 3013162291
- 3010432890
- 3013351723
- 3002808466
- 3010131137
- 9612152
- 3015859709
- 3015173212
- 3012536737
- 3004111573
- 3009965866
- 1000121056
- 3014779787
- 3015453963
- 1318694
- 3011050534
- 2030624
- 2024168
- 8020785
- 1724474
- 3004519921
- 3033589330
- 8010026
- 3013764800
- 3002991496
- 2320762
- 3023245
- 1054241
- 3007830707
- 3009500972
- 2124215
- 3012497308
- 2183744
- 9611665
- 9617594
- 3008261722
- 3008307705
- 3002808467
- 2024024
- 3012931345
- 3015910259
- 3005669815
- 1928237
- 3010079067
- 3012159165
- 3012179728
- 3006891665
- 3007048453
- 3015309643
- 3011660785
- 1319639
- 2024311
- 3038791046
- 3008853977
Source Documents#
510(k) summary PDF not indicated by FDA
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