VPS Rhythm Device with TipTracker Technology
FDA 510(k) clearance K160925 · decided 2016-12-22
Clearance details
- K-number
- K160925
- Device name
- VPS Rhythm Device with TipTracker Technology
- Applicant
- Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-04-04
- Decision date
- 2016-12-22
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded wit recall (Z-0004-2024) | ARROW INTERNATIONAL Inc. | 2023-10-05 |