Rinse Block Connector
FDA 510(k) K771482 · Quinton, Inc.
510(k) numberK771482
Submission
- Device name
- Rinse Block Connector
- Applicant
- Quinton, Inc.
Mchenry, IL, US - Received
- August 4, 1977
- Decision date
- January 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
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| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
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| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
| K964978 | Vital Statistics System (O-Cath Accessory)DQA · Traditional | 05/21/1997SE |
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Questions and answers
When was Rinse Block Connector cleared by the FDA?
Rinse Block Connector (K771482) received a 510(k) decision of Substantially Equivalent on January 3, 1978, 152 days after the submission was received.
What is the product code of K771482?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.