# K962495: Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Sep 12, 1996 after 78 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872981 (1987). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872981: Acs Indeflator Plus (Modification #2), Advanced Cardiovascular Systems, Inc. (1987) Summary page 1.
- K961471: Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve), Advanced Cardiovascular Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K102648: Ant Inflation Device/Ant Inflation Device Compact Pack (2011), 1 descendant of its own
- K133795: Summed Inflation Device Kit (2014), 0 descendants of its own
- K122152: Oxti Inflation Device (2012), 0 descendants of its own

## Recalls of this device
- Mar 11, 2022 · Class II · Z-0925-2022: Due to an increase in complaint trend for leaks and intermittent/loose connections.
- Mar 11, 2022 · Class II · Z-0924-2022: Due to an increase in complaint trend for leaks and intermittent/loose connections.
- Jul 3, 2018 · Class II · Z-0960-2019: Incorrect expiration being entered for one lot.

## Indications for use
The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter. The PLUS 30 PRIORITY PACK™ Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)

Source page: https://510kreport.com/device/K962495
Methodology: https://510kreport.com/methodology