510(k) K183043
- Device
- 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
- Applicant
- Imperative Care Inc.
- 510(k) number
- K183043
- Product code
- NRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-17
- Date received
- 2018-11-02
- Regulation
- 870.1250
- Classification name
- Catheter, Thrombus Retriever
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jake Wolenberg
- Address
- 1359 Dell Ave. Campbell CA US 95008 95008
FDA Registration Numbers#
- 3005168196
- 1220477
- 3012543881
- 3013758550
- 3013556777
- 3013656790
- 3015615738
- 3007007790
- 3008837339
- 3015453963
- 3016540856
- 2029214
- 3002807314
- 3012931345
- 2024311
- 3011370111
- 3014211783
- 3019807891
- 3022392708
- 1721676
- 3030088112
- 3008264254
- 3014162263
- 1721504
- 3009957947
- 3031288142
- 9616664
- 3015701715
- 3016591327
- 3016678045
- 3021520400
- 3014590708
- 3006451981
- 3015550451
- 3008824097
- 3003144120
- 3007628272
- 3010079067
- 1048735
- 3017168767
- 3020954126
- 3012497308
- 2030624
- 3014498720
- 3021009035
- 3008114965
- 3014590707
- 3009337401
- 2011171
- 3008853977
- 3009380063
- 3008881809
- 3009546466
- 3010034260
- 3016522967
- 3015531723
- 2183828
- 2183744
- 3014644549
Source Documents#
Other 510(k) Records For Product Code NRY #
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|---|---|---|---|
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| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical , Ltd. | 2026-03-12 |
| K251357 | Esperance pHLO Aspiration System | Phenox, Ltd. | 2026-01-15 |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 2025-11-10 |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | 2025-10-30 |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical , Ltd. | 2025-10-06 |
| K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | 2025-09-25 |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-08-29 |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2025-08-22 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2025-06-03 |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | 2025-05-28 |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2025-05-19 |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-04-30 |