# K032050: Perivac Kit

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 8, 2003 after 37 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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. The FDA summary names its predicate without a number.
- (no number) Manfield PeriVac Kit: named in the summary without a submission number

## Recalls of this device
- Sep 29, 2003 · Not classified · Z-0071-04: The product has the potential to break during withdrawal process.

## Indications for use
The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial eflusion or tamponade.

Source page: https://510kreport.com/device/K032050
Methodology: https://510kreport.com/methodology