Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
FDA 510(k) clearance K212165 · decided 2022-03-10
Clearance details
- K-number
- K212165
- Device name
- Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
- Applicant
- Innovative Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-07-12
- Decision date
- 2022-03-10
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- PNE
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innovative Health
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Reprocessed Agilis NxT Steerable Introducer (K250305) | Innovative Health | 2026-01-07 |
| Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (K250314) | Surgical Instrument Service and Savings, Inc. | 2025-12-19 |
| Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (K232037) | Innovative Health, LLC | 2024-04-04 |
| Reprocessed Agilis NxT Steerable Introducer (K230376) | Innovative Health, LLC | 2023-08-07 |
| Reprocessed Agilis NxT Steerable Introducer (K170311) | Innovative Health, LLC | 2017-06-02 |
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |
Recalls involving this device
No recalls on record reference this clearance.