510(k) K192886
- Device
- OmniWire Pressure Guide Wire, 185 Cm Straight Tip, OmniWire Pressure Guide Wire, 185 Cm J-Tip
- Applicant
- Volcano Corporation
- 510(k) number
- K192886
- Product code
- DXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-26
- Date received
- 2019-10-10
- Regulation
- 870.1120
- Classification name
- Blood Pressure Cuff
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jenny Fu
- Address
- 3721 Valley Centre Dr., Suite 500 San Diego CA US 92130 92130
FDA Registration Numbers#
- 2248146
- 3010131137
- 3014279513
- 3007138831
- 3006950086
- 9616088
- 3004605321
- 3020968442
- 1061124
- 3012179728
- 1000393132
- 3006010712
- 3010155661
- 3033589330
- 2134265
- 3008403546
- 9616684
- 3002807314
- 3011564431
- 2528981
- 2024311
- 3013943846
- 2182208
- 3030447506
- 1721676
- 1720929
- 3008264254
- 3014162263
- 3009526575
- 3003780911
- 3004748528
- 9616662
- 3006425876
- 3007146453
- 3011137372
- 3010419931
- 2024168
- 3016678045
- 1028232
- 2184149
- 3013288201
- 3008988055
- 3012050423
- 3015124694
- 3015489752
- 3014656749
- 1649395
- 1123137
- 3001124136
- 3006946276
- 3012497308
- 3002244583
- 1056553
- 3014461810
- 3008114965
- 3014579161
- 3017961114
- 3008439199
- 3010882065
- 3024682301
- 8010026
- 3036802499
- 2011171
- 3007695959
- 3009546466
- 9614758
- 3003790304
- 3003289691
- 2020394
- 3003775027
- 1054811
- 3008363989
- 3015522130
- 3009564766
- 1016427
- 1000563940
- 3030733800
- 1220477
- 9681834
Source Documents#
Other 510(k) Records For Product Code DXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | 2026-05-06 |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | 2026-02-13 |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | 2026-01-09 |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | 2025-12-16 |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | 2025-09-03 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. | 2025-07-15 |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | 2024-10-31 |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | 2024-03-20 |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023-12-21 |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) | Shenzhen Plinma Technology Co. , Ltd. | 2023-11-29 |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023-06-28 |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | Cardicare Company, Ltd. | 2022-11-28 |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-11-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases