Silicone Bi-Lumen Irrigation Embolectomy Catheter
510(k) K893680
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893680 | Date1 Aug 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Silicone Bi-Lumen Irrigation Embolectomy Cath.
- 510(k) Number
- FDA Product Code
- DXE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5150
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a silicone bi-lumen irrigation embolectomy catheter, classified under the FDA’s embolectomy catheter category (DXE). It is designed for the mechanical removal of thromboemboli—blood clots that have migrated within the vascular system—using a dual-lumen system for both irrigation and aspiration. The catheter’s silicone construction and dual-lumen design facilitate precise clot retrieval while minimizing vessel trauma during the procedure. Its use is confined to interventional cardiology settings where percutaneous embolectomy is performed.
The Silicone Bi-Lumen Irrigation Embolectomy Catheter is supplied sterile and intended for single-use in catheterization laboratories. It is regulated under FDA’s 510(k) clearance (K893680, Traditional pathway, Cardiovascular Advisory Committee, SESE decision) and falls under Class II regulatory classification (DXE product code, regulation 870.5150). No MRI safety information or reusable variants are specified; storage and handling must comply with sterile medical device protocols. Authorizations are limited to the original 1989 submission and do not extend to modified or new models.
Other devices from Cathlab Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Silicone Bi-Lumen Irrigation Embolectomy Catheter used for?
This catheter is specifically designed for the mechanical removal of thromboemboli—blood clots that have migrated within the vascular system—during percutaneous embolectomy procedures in interventional cardiology settings. Its dual-lumen system allows simultaneous irrigation and aspiration, which helps reduce vessel trauma while ensuring effective clot retrieval.
How is the Silicone Bi-Lumen Irrigation Embolectomy Catheter supplied and intended for use?
The catheter is supplied sterile and is intended exclusively for single-use in catheterization laboratories. It is not designed for reuse or reprocessing, and adherence to sterile medical device protocols is required for handling and storage to maintain its integrity and safety.
Is the Silicone Bi-Lumen Irrigation Embolectomy Catheter reusable?
No, this catheter is explicitly intended for single-use only. Reuse is not supported by the manufacturer or regulatory clearance, as it could compromise sterility and device performance. Always follow the manufacturer’s instructions for proper disposal after a single procedure.
What regulatory pathway does the Silicone Bi-Lumen Irrigation Embolectomy Catheter follow?
The device is regulated under the FDA’s 510(k) clearance pathway, specifically through the Traditional pathway, and was reviewed by the Cardiovascular Advisory Committee. It received a Substantially Equivalent (SESE) decision in 1989 under product code DXE (Embolectomy Catheters) and regulation 870.5150. No additional modifications or new models have been authorized beyond the original submission.
How should the Silicone Bi-Lumen Irrigation Embolectomy Catheter be stored?
Since the catheter is sterile and single-use, it must be stored in accordance with standard sterile medical device protocols to preserve its integrity. Ensure the packaging remains unopened and undamaged until immediate use. Avoid exposure to extreme temperatures, moisture, or contamination, as these factors could compromise sterility and functionality.