# P190008: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Nov 21, 2019 after 232 days
- Product code: PRC (Drug-Coated 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-1043-2022: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

Source page: https://510kreport.com/device/P190008
Methodology: https://510kreport.com/methodology