Impra Dual Lumen Subclavian Catheter
by Impra, Inc.
510(k) K872163
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872163 | Date30 Oct 1987 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Impra Dual Lumen Subclavian Catheter is a dual-lumen venous catheter designed for subclavian vein access. It provides two separate channels for simultaneous infusion of fluids or medications, blood sampling, or monitoring of central venous pressure. This configuration supports critical care procedures requiring dual-pathway vascular access. The device is classified under venous catheters with multiple lumens, enabling versatile hemodynamic and therapeutic interventions.
This catheter is intended for single-use and is supplied sterile. It is regulated under FDA 510(k) clearance (K872163) and falls under the product code DQY, classified within the Cardiovascular advisory committee. The device is not indicated for MRI use and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications.