# K934697: Microvasive Maxforce

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 16, 1994 after 228 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061787: Maxforce TTS Single-Use Balloon Dilator (2006), 3 descendants of its own
- K111030: E.G. Scan (TM) Esophagoscope System (2011), 2 descendants of its own
- K120702: E.G. Scan II Esphagoscope System (2012), 1 descendant of its own
- K131131: E.G. Scan (TM) II Esophagoscope System (2013), 0 descendants of its own

## Recalls of this device
- Apr 29, 2003 · Not classified · Z-0831-03: Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr

Source page: https://510kreport.com/device/K934697
Methodology: https://510kreport.com/methodology