# P140010: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and  IN.PACT 018 Paclitax

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Dec 30, 2014 after 215 days
- Product code: ONU (Drug-Eluting Peripheral Transluminal Angioplasty Catheter)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 23, 2022 · Class II · Z-1042-2022: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

Source page: https://510kreport.com/device/P140010
Methodology: https://510kreport.com/methodology