# K973113: Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 10, 1997 after 82 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K851647 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K934411: Meadox Surgimed Olbert Catheter System Noprofile, Meadox Medicals, Div. Boston Scientific Corp. (1994) Summary page 3.
- K945576: Meadox Surgimed Noprofile (TM) Olbert Catheter System (R), Meadox Medicals, Div. Boston Scientific Corp. (1995) Summary page 3.
- K952887: Noprofile Olbert Catheter System Balloon Dilatation Catheter, Meadox Medicals, Div. Boston Scientific Corp. (1995). Our OCR of the scanned summary read K952867, FDA’s number for Remanium:GM 700, GM 380, GM 800, GFH (Dentauraum, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NoProfile®”.
- K851647: Olbert Catheter System for Biliary Tract Dilatatio, Meadox Surgimed, Inc. (1985) Summary page 3.
- K961438: Ballon Dilatation Catheter, Boston Scientific Corp (1996) Summary page 3.

## Most influential descendants
- K010714: Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (2003), 0 descendants of its own

## Indications for use
The Modified Olbert® Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label * * The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.

Source page: https://510kreport.com/device/K973113
Methodology: https://510kreport.com/methodology