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#
- 3004519921
- 3013557562
- 3015859709
- 3013656790
- 2135147
- 3014590708
- 3015522130
- 3016678045
- 1824619
- 3000247873
- 3014461810
- 1649395
- 3007064586
- 3005580113
- 3039642752
- 3005737652
- 3007138831
- 3000126629
- 3013764800
- 8010026
- 3009546466
- 2219920
- 3015173212
- 3017210488
- 1724474
- 1720929
- 2939520
- 3005941719
- 3009957947
- 1055236
- 3006891611
- 3036802499
- 3013595987
- 1423537
- 3002244583
- 2024168
- 3007830707
- 3015124694
- 1064858
- 3010155661
- 3035372913
- 3012159165
- 3008002401
- 8023054
- 1226348
- 2248146
- 3020954746
- 3007635982
- 3009490946
- 3017961114
- 3010419931
- 3010665433
- 3007695959
- 3004605321
- 9681834
- 1018233
- 3039020025
- 8043892
- 2017865
- 3035642068
- 2182269
- 9612812
- 3024743081
- 9616684
- 3027260597
- 1319211
- 3002807314
- 3013556777
- 2183744
- 1417485
- 1221806
- 3030574705
- 9610139
- 3014716786
- 3015910259
- 2134265
- 3007361214
- 3014977413
- 3007284006
- 1313046
Source Documents#
Other 510(k) Records For Product Code DXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026-06-22 |
| 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 |
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