Tubing Connector #10-810-60 100/PKG Non-Sterile

FDA 510(k) K862722 · Mercury Enterprises, Inc.

Substantially Equivalent

510(k) numberK862722

Submission

Device name
Tubing Connector #10-810-60 100/PKG Non-Sterile
Applicant
Mercury Enterprises, Inc.
Clearwater, FL, US
Received
July 17, 1986
Decision date
August 11, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKY – Connector, Tubing, Dialysate
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FKY

510(k)DeviceApplicantDecision
K991003Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock…FKY · Traditional Dayspring Medical, Inc.06/09/1999SE
K830002Capd Color-Guard System PrepkitFKY · Traditional Abbott Laboratories03/11/1983SE
K771428Tenckhoff Peritoneal Tubing Adapt.FKY · Traditional Quinton, Inc.10/18/1977SE

More from Quinton, Inc.

510(k)DeviceDecision
K885342Genny Denny IV ShieldFMK · Traditional 03/30/1989SE
K871789Intecare Pediatric Urine CollectorFFH · Traditional 08/10/1987SE

Questions and answers

When was Tubing Connector #10-810-60 100/PKG Non-Sterile cleared by the FDA?

Tubing Connector #10-810-60 100/PKG Non-Sterile (K862722) received a 510(k) decision of Substantially Equivalent on August 11, 1986, 25 days after the submission was received.

What is the product code of K862722?

The FDA product code is FKY – Connector, Tubing, Dialysate, a Class II (moderate risk) device regulated under 21 CFR 876.5820.