# K092361: Reef HP 0.035 Otw Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Invatec S.P.A.
- Decided: Oct 29, 2009 after 86 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042538 (2004). 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)
- K062809: Admiral Xtreme Pta Catheter, Invatec Innovative Technologies (2006) Summary page 1.
- K032737: Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta, Cordis Europa, N.V. (2003) Summary page 1.

## Most influential descendants
- K123358: Pacific Plus (2013), 1 descendant of its own
- K202800: Pacific Plus PTA Catheter (2020), 0 descendants of its own
- K121265: Amphirion Plus Pta Catheter (2012), 0 descendants of its own

## Indications for use
The REEF HP 0.035" OTW PTA Balloon Dilatation Catheters are intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K092361
Methodology: https://510kreport.com/methodology