Who is the manufacturer of OLYMPUS B5-2C/B7-2C BALLOON CATHETER?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS B5-2C/B7-2C BALLOON CATHETER (K962901).

What is the FDA product code for OLYMPUS B5-2C/B7-2C BALLOON CATHETER?

EOQ. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for OLYMPUS B5-2C/B7-2C BALLOON CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OLYMPUS B5-2C/B7-2C BALLOON CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OLYMPUS B5-2C/B7-2C BALLOON CATHETER

Q: What are the predicate devices for OLYMPUS B5-2C/B7-2C BALLOON CATHETER?

Olympus B5-2C/B7-2C Biliary Balloon Catheter (K904669).

K962901 · Olympus America, Inc. · EOQ · Aug 20, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K962901
Device Name	OLYMPUS B5-2C/B7-2C BALLOON CATHETER
Applicant	Olympus America, Inc.
Product Code	EOQ · Ear, Nose, Throat
Decision Date	Aug 20, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2
Attributes	Therapeutic

Intended Use

B5-2C Balloon Catheter (Color of Branch - Blue) The B5-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.0 mm. B7-2C Balloon Catheter (Color of Branch - Yellow) The B7-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.8 mm.

Device Story

Balloon catheter accessory for Olympus endoscopes; introduced through instrument channel to bronchial site. Components: inflatable balloon, catheter, bifurcation, irrigation port, air feed cap, stopcock. B5 model (5 French) for 2.0mm channels; B7 model (7 French) for 2.8mm channels. Used by physicians during bronchoscopy for diagnostic imaging (bronchography), therapeutic delivery (medicine/saline), foreign body retrieval, and hemostasis via tamponade. Color-coded branches (blue/yellow) for identification. 1050mm length.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Catheter-based balloon system; 5 French (B5) and 7 French (B7) diameters; 1050 mm length. Manual inflation/irrigation via stopcock and port. Color-coded bifurcation branches. Compatible with Olympus endoscopes (2.0mm or 2.8mm channels).

Indications for Use

Indicated for selective endoscopic bronchography, bronchial medicine injection, saline injection for bronchoalveolar lavage, bronchial foreign body removal, and bronchial hemostasis (tamponade) in patients undergoing bronchoscopy.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

Olympus B5-2C/B7-2C Biliary Balloon Catheter (K904669)

Related Devices

K962925 — OLYMPUS B-5/B-7 SERIESBALLOON CATHETER · Olympus America, Inc. · Oct 25, 1996
K171492 — B7 2C Occlusion Balloon · Spiration, Inc. · Nov 20, 2017
K250118 — Disposable Balloon Catheter B5-2C · Olympus Medical Systems Corporation · Jun 4, 2025
K213434 — Elation Pulmonary Balloon Dilation Catheter · Merit Medical Systems, Inc. · Mar 8, 2022
K161392 — Elation Pulmonary Balloon Dilation · Merit Medical Systems, Inc. · Sep 1, 2016

Submission Summary (Full Text)

{0} K962901 # AUG 20 1996 510 (k) SUMMARY ## OLYMPUS B5-2C/B7-2C BALLOON CATHETER | Device Name: | Olympus B5-2C/B7-2C Balloon Catheters | | --- | --- | | Common/Usual Name: | Balloon Catheter | | Classification Name: | Bronchoscope and Accessories | | Predicate Devices: | Olympus B5-2C/B7-2C Biliary Balloon Catheter (K904669) | | Submitted By: (Contact Person) | Mr. Barry Sands Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-5474 | | Summary Preparation Date: | July 9, 1996 | ## Statement of Intended Use **B5-2C Balloon Catheter (Color of Branch - Blue)** The B5-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the *minimum* channel size of 2.0 mm. **B7-2C Balloon Catheter (Color of Branch - Yellow)** The B7-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the *minimum* channel size of 2.8 mm. ## Indications for Use: **B5-2C/B7-2C Balloon Catheters (Two Models)** Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade). ## Device Description The subject balloon catheters are designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through the instrument channel of the endoscope. 29 {1} The subject device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap, and stopcock. The B5 series balloon catheter is 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloon catheter is 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified then by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. The length of both catheters is 1050 mm. ## General Safety In conclusion, when compared with the predicate biliary balloon (K904669), the subject Olympus B5-2C/B7-2C Balloon Catheter does not incorporate any significant change in the design, specifications, or method of operation that could affect the safety or efficacy of the subject devices.