510(k) K163560
- Device
- Reprocessed AcuNav Diagnostic Ultrasound Catheter
- Applicant
- Innovative Health, LLC.
- 510(k) number
- K163560
- Product code
- OWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-12
- Date received
- 2016-12-19
- Regulation
- 870.1200
- Classification name
- Reprocessed Intravascular Ultrasound Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rafal Chudzik
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257
FDA Registration Numbers#
- 3011610434
- 2183744
- 2182269
- 3009888344
- 2030404
- 2090040
- 3009350690
- 3019807891
- 3011024991
- 2032112
- 3008452825
- 3005467144
- 2011171
- 3011276773
- 3012179728
- 3038966633
- 3015988948
- 1061124
- 3005334138
Source Documents#
Other 510(k) Records For Product Code OWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Surgical Instrument Service and Savings, Inc. | 2025-06-05 |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | 2025-05-12 |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | Surgical Instrument Service and Savings, Inc. | 2025-03-10 |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | Surgical Instrument Service and Savings, Inc. | 2024-09-10 |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | 2023-12-15 |
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC | 2023-10-24 |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | 2023-08-25 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | 2023-07-25 |
| K231588 | ViewFlex™ Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023-06-30 |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | 2023-06-06 |
| K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023-05-03 |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2023-02-03 |
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | 2022-12-19 |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC | 2022-05-25 |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2020-11-20 |
Legacy Summary#
summary
FDA Review#
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