# K960563: Scimed Sceptor & Sceptor Exchange Ptca Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Apr 29, 1996 after 80 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 5 cite it directly.
5 of 36 devices 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) SCIMED Sceptor Guide Wire: named in the summary without a submission number
- (no number) SCIMED Sceptor Exchange Guide Wire: named in the summary without a submission number
- (no number) SCIMED ChoICE Guide Wire: named in the summary without a submission number

## Most influential descendants
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K962572: Scimed Choice PT Vision Ptca Guide Wire (1996), 16 descendants of its own
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (2000), 15 descendants of its own
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), 14 descendants of its own
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX (2003), 12 descendants of its own

## Indications for use
The SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and ewelnge of PTCA balloon catheters and other therapeutic devices during angioplasty. The devices are provided sterile and intended for one procedure only.

Source page: https://510kreport.com/device/K960563
Methodology: https://510kreport.com/methodology