ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
FDA 510(k) clearance K102238 · decided 2011-02-01
Clearance details
- K-number
- K102238
- Device name
- ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-09
- Decision date
- 2011-02-01
- Days to decision
- 176 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long recall (Z-2883-2011) | Arrow International Inc | 2011-07-30 |