510(k) K193279
- Device
- Comet II Pressure Guidewire
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K193279
- Product code
- DXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-23
- Date received
- 2019-11-27
- Regulation
- 870.2870
- Classification name
- Transducer, Pressure, Catheter Tip
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kimberly Berg
- Address
- Three Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3015173212
- 3017636737
- 3008061490
- 2183744
- 2134265
- 1721686
- 2029275
- 2015691
- 9611665
- 2184149
- 3004748528
- 2133928
- 3030733800
- 2134285
- 2320762
- 3027605168
- 1043214
- 3004091615
- 3015309643
- 3008363989
- 3006950086
- 3008388260
- 2939520
- 3010273872
- 9615817
- 1054811
- 3033589330
- 2134243
- 2124215
- 3030446844
- 3009490946
- 3007029079
- 3004111573
- 9612051
- 1000121056
- 3009600098
- 1644312
- 3004832480
- 3010421104
- 3032916632
- 3012260771
- 3005941719
- 3009564766
- 2011171
- 3005232773
- 3006082230
- 3018784828
- 3017961114
- 3012494290
- 1319639
- 3013943846
- 2648045
- 3012536737
- 3013557562
- 1018233
- 2024168
- 3010432890
- 3000126629
- 9681260
- 3005334138
- 3003493679
- 3014461810
- 3043226252
- 1222140
Source Documents#
Other 510(k) Records For Product Code DXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | 2026-01-16 |
| K241418 | OptoMonitor 3 | Opsens, Inc. | 2025-02-12 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024-07-17 |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022-12-22 |
| K202943 | OptoMonitor 3 | Opsens, Inc. | 2020-11-24 |
| K193620 | OptoMonitor 3 | Opsens, Inc. | 2020-06-18 |
| K192340 | OptoMonitor | Opsens, Inc. | 2019-12-12 |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | 2019-08-14 |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019-05-01 |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017-10-23 |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | 2017-03-10 |
| K161263 | OptoMonitor II | Opsens, Inc. | 2016-09-13 |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016-08-15 |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015-10-06 |
Legacy Summary#
summary
FDA Review#
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