Ultracon Ultrafiltrator
FDA 510(k) K981253 · Interpore Intl.
510(k) numberK981253
Submission
- Device name
- Ultracon Ultrafiltrator
- Applicant
- Interpore Intl.
Irvine, CA, US - Received
- April 6, 1998
- Decision date
- December 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
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Questions and answers
When was Ultracon Ultrafiltrator cleared by the FDA?
Ultracon Ultrafiltrator (K981253) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 249 days after the submission was received.
What is the product code of K981253?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.