Coaxial Acute Catheter
by Akcess Medical Products, Inc.
510(k) K931120
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931120 | Date14 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
A Coaxial Acute Catheter is a catheter, subclavian, as defined in the device data. It is a medical device classified under class 2.
The device received FDA 510(k) clearance (K931120) on January 14, 1994, and is substantially equivalent to a predicate device. It is manufactured by Akcess Medical Products, Inc., located in New Brunswick, NJ 08902, and is associated with the gastroenterology and urology medical specialties.
Other devices from Akcess Medical Products, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the COAXIAL ACUTE CATHETER used for?
The COAXIAL ACUTE CATHETER is a subclavian catheter indicated for use in gastroenterology and urology procedures, as specified in its FDA 510(k) clearance documentation.
When was the COAXIAL ACUTE CATHETER cleared by the FDA?
The device received FDA 510(k) clearance under K931120 on January 14, 1994, and was determined to be substantially equivalent to a predicate device.
Who manufactures the COAXIAL ACUTE CATHETER and where are they located?
The COAXIAL ACUTE CATHETER is manufactured by Akcess Medical Products, Inc., located at 201 N. Center Dr., New Brunswick, NJ 08902, United States.