Tenckhoff Peritoneal Tubing Adapt.
FDA 510(k) K771428 · Quinton, Inc.
510(k) numberK771428
Submission
- Device name
- Tenckhoff Peritoneal Tubing Adapt.
- Applicant
- Quinton, Inc.
Mchenry, IL, US - Received
- August 1, 1977
- Decision date
- October 18, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
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| K862722 | Tubing Connector #10-810-60 100/PKG Non-SterileFKY · Traditional | Mercury Enterprises, Inc. | 08/11/1986SE |
| K830002 | Capd Color-Guard System PrepkitFKY · Traditional | Abbott Laboratories | 03/11/1983SE |
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Questions and answers
When was Tenckhoff Peritoneal Tubing Adapt. cleared by the FDA?
Tenckhoff Peritoneal Tubing Adapt. (K771428) received a 510(k) decision of Substantially Equivalent on October 18, 1977, 78 days after the submission was received.
What is the product code of K771428?
The FDA product code is FKY – Connector, Tubing, Dialysate, a Class II (moderate risk) device regulated under 21 CFR 876.5820.