510(k) K203803
- Device
- VASOBand Vascular Compression Device
- Applicant
- Vasoinnovations, Inc.
- 510(k) number
- K203803
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-26
- Date received
- 2020-12-28
- 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
- Yes
Related Records
Applicant Contact
- Contact
- Rajendra Gurudas Sardesai
- Address
- 1260 Huntington Dr. Suite 208 South Pasadena CA US 91030 91030
FDA Registration Numbers
- 3030078769
- 3012050423
- 1423537
- 3008998256
- 2029275
- 2024024
- 1643116
- 1056553
- 2528981
- 9610612
- 2242352
- 3031282706
- 3004102031
- 9680837
- 3032534
- 3011642792
- 1423662
- 3006947772
- 1625519
- 3005593675
- 1118880
- 1625425
- 3009142291
- 3009265194
- 3005809810
- 3009810261
- 2648623
- 3007830707
- 3010202439
- 9616088
- 1450019
- 2011171
- 1421101
- 1018233
- 3001650535
- 3004608878
- 1054241
- 8010422
- 1225991
- 2245304
- 3022815697
- 3007014520
- 3010601992
- 3031571797
- 1032347
- 8010372
- 1927395
- 3008729892
- 9710524
- 3018312328
- 3008717566
- 3020031299
- 1220477
- 1923569
- 3003761012
- 2219920
- 3010055973
- 9611112
- 3008002401
- 9611484
- 3010652124
- 1055236
- 1016427
- 1720747
- 3004111573
- 9616972
- 3033536312
- 1061927
- 3015547863
- 1644312
- 3021140368
- 3009164961
- 2953359
- 3008500478
- 3010141307
- 3032916632
- 2126670
- 3038185753
- 2134812
- 1643817
Source Documents
Other 510(k) Records For Product Code DXC
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|---|---|---|---|
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| K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023-02-28 |
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| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 |