Catheter, Balloon Type
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
751 adverse event reports on file
- GATEWAY MR 2.0MM X 9MM - JPJul 27, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00021
- GATEWAY OTW 1.5MM X 15MM - CEJul 21, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00019
- GATEWAY OTW 1.5MM X 15MM - CEJul 21, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00020
- PNEUMATIC INFLATORMay 20, 2026MalfunctionBoston Scientific Corporation3005099803-2026-01991
- PNEUMATIC INFLATORMay 7, 2026MalfunctionBoston Scientific Corporation3005099803-2026-01680
- GATEWAY OTW 1.5MM X 9MM - CEApr 6, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00010
- GATEWAY OTW 3.0MM X 15MM - CEMar 25, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00007
- GATEWAY OTW 2.0MM X 15MM - CEMar 18, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00006
- RUSCHFeb 27, 2026MalfunctionTeleflex Incorporated24469092
- GATEWAY MR 2.0MM X 9MM - JPFeb 26, 2026MalfunctionBoston Scientific - Minn3008853977-2026-00004
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
36 firms currently registered for this product code
Cook Incorporated
Bloomington, IN, US
Telemed Systems
Northborough, MA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Medgyn Products, Inc.
Westmont, IL, US
Wrp Asia Pacific Sdn. Bhd.
SALAK TINGGI, SEPANG Selangor, MY
Rece International Corp.
Miami, FL, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Ribbel International Ltd.
SONEPAT Haryana, IN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Spinal Stabilization Technologies, Ltd
Kilkenny, IE
Dmed
Seongnam-si Gyeonggi, KR
Spineology Inc.
Saint Paul, MN, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Hangzhou Fushan Medical Appliance Co., Ltd.
Hangzhou City Zhejiang, CN
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Isomedix Operations, Inc.
Minneapolis, MN, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Custom Assemblies, Inc.
PINE LEVEL, NC, US
Boston Scientific Corporation
Marlborough, MA, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Teleflex Medical Sdn. Bhd.
KAMUNTING Perak, MY
Fisbol International S.a.
Montevideo, UY
510(k) clearances
5 clearances for this product code
- Byron MedicalMay 30, 1986
K861877 · BYRON WORD BARTHOLIAN GLAND CATHETER
- Loseff Medical Designers, Ltd.Sep 26, 1980
K802025 · BALLOON RETENTION CHEST CATHETER
- Electro-Catheter Corp.Jun 11, 1979
K790444 · ELECATH MULTI-PURPOSE ARTERIAL SURGER
- Medi-Tech, Inc.Mar 6, 1979
K781772 · CATHETER, TRANSLUMINAL BALLOON
- National Catheter Co. Div. MallinckrodtDec 15, 1978
K781665 · TUBE, LEATHERMAN/IMBRUCE