510(k) K253070
- Device
- Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
- Applicant
- Medline Industries, LP
- 510(k) number
- K253070
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-20
- Date received
- 2025-09-23
- Regulation
- 870.4450
- Classification name
- Clamp, Vascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Payal Solanki
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers
- 1423662
- 1450662
- 1220351
- 9680515
- 1625519
- 3022815697
- 1416980
- 3016096142
- 3012507533
- 8010871
- 3011564431
- 1421101
- 3008002401
- 2183744
- 3012536737
- 2032098
- 1644312
- 3016704581
- 3010055973
- 2648612
- 1720747
- 3031571797
- 1522875
- 3021140368
- 1225991
- 3008717566
- 9610612
- 3010202439
- 3010131137
- 2246552
- 1062741
- 3010141307
- 3032534
- 1319660
- 1423537
- 1721676
- 2183620
- 3033589330
- 3006950086
- 9614747
- 1219659
- 2024024
- 3006015326
- 3010687973
- 3009605245
- 2916714
- 1018233
- 3009164961
- 3005593675
- 8010422
- 3005334138
- 1625425
- 8010303
- 8030107
- 3009142291
- 1043214
- 3006554912
- 9612086
- 1055236
- 1056350
- 8010591
- 3007648354
- 1643116
- 1450019
- 3018312328
- 2953359
- 9615817
- 9710524
- 3017056829
- 1225598
- 1118880
- 1927395
- 3008258694
- 3016733629
- 1417592
- 3006947772
- 3014342096
- 3008998256
- 1724474
- 3001650535
Source Documents
Other 510(k) Records For Product Code DXC
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|---|---|---|---|
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| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2021-01-26 |
| K201695 | Patent Hemostasis Band (PH Band) | Medical Ingenuities | 2020-10-30 |