# K970054: Tandemrx

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 10, 1997 after 34 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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) Microvasive Tandem XL Cannula: named in the summary without a submission number

## Most influential descendants
- K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 (2001), 6 descendants of its own
- K040137: Wilson-Cook Usw Cap and Wire Lock (2004), 4 descendants of its own
- K213483: SnapLoc Wire Lock (2022), 0 descendants of its own
- K220247: Guidewire Locking Device (2022), 0 descendants of its own
- K210353: AutoCap RX (2021), 0 descendants of its own

## Indications for use
The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.

Source page: https://510kreport.com/device/K970054
Methodology: https://510kreport.com/methodology