TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
FDA 510(k) clearance K003006 · decided 2000-10-27
Clearance details
- K-number
- K003006
- Device name
- TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-26
- Decision date
- 2000-10-27
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Arrow Intl.
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 recall (Z-2395-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes recall (Z-2825-2015) | Arrow International Inc | 2015-09-30 |