Uresil Vascu-Flo Infusion Catheter
FDA 510(k) K980278 · Uresil Corp.
510(k) numberK980278
Submission
- Device name
- Uresil Vascu-Flo Infusion Catheter
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- January 26, 1998
- Decision date
- November 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | 04/24/1998SE |
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| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary…FGE · Traditional | 08/29/1997SE |
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Questions and answers
When was Uresil Vascu-Flo Infusion Catheter cleared by the FDA?
Uresil Vascu-Flo Infusion Catheter (K980278) received a 510(k) decision of Substantially Equivalent on November 20, 1998, 298 days after the submission was received.
What is the product code of K980278?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.