# K980128: Baladi Inverter with Coaxial Aortic Punch

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Medical Solutions, Inc.
- Decided: Jul 24, 1998 after 191 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K800122 (1980). 1 ancestor in all.
5 later devices descend from it; 1 cites 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)
- K800122: Hancock Aortic Punch, Hancock Laboratories, Inc. (1980) Summary page 2.
- (no number) Debakey Vascular Clamp: named in the summary without a submission number
- (no number) Cooley Vascular Clamp: named in the summary without a submission number
- (no number) Medtronic Punch: named in the summary without a submission number
- (no number) Davis + Geck CardioPunch: named in the summary without a submission number

## Most influential descendants
- K022880: Guidant Proximal Seal System, Models PSS-4500 & PS-4500 (2002), 4 descendants of its own
- K080169: Heartstring Iii Proximal Seal System (2008), 3 descendants of its own
- K130382: Heartstring Iii Proximal Seal System (2013), 2 descendants of its own
- K203307: VIOLA (2021), 1 descendant of its own
- K230248: VIOLA (2023), 0 descendants of its own

## Indications for use
The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.

Source page: https://510kreport.com/device/K980128
Methodology: https://510kreport.com/methodology