Modified Use of Pull-Apart Introducer Set
by Quinton, Inc. 510(k)
Active
510(k) K871730
Overview
The Modified Use of Pull-Apart Introducer Set is a catheter, peritoneal dialysis, single use device. It is classified as a Class II medical device under regulation number 876.5630 and product code FKO.
This device received FDA 510(k) clearance (K871730) on May 18, 1987, following a traditional review process. It is indicated for use in gastroenterology and urology specialties, as determined by the advisory committee review. The device is supplied as a single-use introducer set and is not intended for reuse.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871730 | Date18 May 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FKO
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the Modified Use of Pull-Apart Introducer Set used for?
This device is a catheter designed for peritoneal dialysis and is indicated for use in gastroenterology and urology specialties, as determined by the advisory committee review during its FDA 510(k) clearance process.
Is the Modified Use of Pull-Apart Introducer Set sterile and single-use?
Yes, the device is supplied as a single-use introducer set and is not intended for reuse, ensuring sterility and patient safety for each procedure.
What regulatory pathway was used for the Modified Use of Pull-Apart Introducer Set?
The device received FDA 510(k) clearance (K871730) on May 18, 1987, following a traditional review process, and was found substantially equivalent to a predicate device.