# K963307: GDC Patient Return Electtrode Model 45021

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Dec 17, 1996 after 117 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- 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 K851522 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851522: Diagnostic Ecg Disposable Electrode, Sentry Medical Products, Inc. (1985) Summary page 1.
- K861036: E7509 Polyhesive II Patient Return Electrode, Valleylab, Inc. (1986) Summary page 1.
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 1.

## Indications for use
The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

Source page: https://510kreport.com/device/K963307
Methodology: https://510kreport.com/methodology