Uresil Dilator with Radiopaque Marker
FDA 510(k) K980282 · Uresil Corp.
510(k) numberK980282
Submission
- Device name
- Uresil Dilator with Radiopaque Marker
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- January 26, 1998
- Decision date
- April 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K093653 | Uresil Gastrostomy Catheter Kit , Model GCL-630HBKKNT · Traditional | 02/23/2010SESK |
| K053245 | GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter…FGE · Special | 12/20/2005SE |
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | 08/19/2004SE |
| K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP…FGE · Special | 01/04/2001SE |
| K980278 | Uresil Vascu-Flo Infusion CatheterDQY · Traditional | 11/20/1998SE |
| K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingLJE · Traditional | 09/10/1998SE |
| K980889 | Uresil Nephro-Ureteral StentLJE · Traditional | 04/08/1998SE |
| K972582 | Uresil GuidewireFGE · Traditional | 11/21/1997SE |
| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary…FGE · Traditional | 08/29/1997SE |
| K953923 | Uresil Introducing NeedleKNW · Traditional | 09/08/1995SE |
Questions and answers
When was Uresil Dilator with Radiopaque Marker cleared by the FDA?
Uresil Dilator with Radiopaque Marker (K980282) received a 510(k) decision of Substantially Equivalent on April 24, 1998, 88 days after the submission was received.
What is the product code of K980282?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.