510(k) K230028
- Device
- Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- Applicant
- Cardinal Health200, LLC
- 510(k) number
- K230028
- Product code
- JOW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-03
- Date received
- 2023-01-04
- Regulation
- 870.5800
- Classification name
- Sleeve, Limb, Compressible
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Katy Piper
- Address
- 3651 Birchwood Dr. Waukegan IL US 60085 60085
FDA Registration Numbers
- 1423537
- 2031823
- 1648700
- 3016000973
- 2029275
- 3007778244
- 3012446970
- 3034205725
- 1721293
- 3014947294
- 1526350
- 3027500264
- 3033648890
- 3014694377
- 3032062344
- 3003619590
- 3038295706
- 3010148613
- 2028253
- 3010694026
- 3005619970
- 1047843
- 9616088
- 3018094310
- 3014342658
- 2011171
- 3034520
- 8043439
- 3009247326
- 1450371
- 3007420694
- 1928237
- 2027046
- 3010246951
- 3030517288
- 1018470
- 3010256111
- 2424387
- 3007141284
- 3003801933
- 3011539161
- 9616933
- 3012174974
- 3006792041
- 3017618673
- 1921846
- 3004105270
- 3033981998
- 3004116008
- 9616086
- 3011554160
- 1061927
- 3011200334
- 3011219270
- 3011118518
- 3009155917
- 1649518
- 3033511104
- 3004183730
- 9680841
- 3009437400
- 1061124
- 9612030
- 3043226252
- 3031916218
- 3005012805
- 1650907
- 3012292104
- 3030441550
- 1220908
- 3029871637
- 3011529836
- 3029905040
- 3021767551
- 3012341425
- 3010308146
- 3014144875
- 3009211636
- 3017264244
- 3030063003
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOW
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|---|---|---|---|
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | 2026-02-24 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 |
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| K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025-08-18 |
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| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 |
| K241746 | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF | United Medical Resources, LLC | 2024-10-04 |
| K232640 | Venowave VW5 | Thermabright | 2024-06-25 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024-03-06 |