Uresil Valve Cutter with Interchangeable Heads
FDA 510(k) K930011 · Uresil Corp.
510(k) numberK930011
Submission
- Device name
- Uresil Valve Cutter with Interchangeable Heads
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- January 4, 1993
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| 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 |
| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | 04/24/1998SE |
| 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 |
Questions and answers
When was Uresil Valve Cutter with Interchangeable Heads cleared by the FDA?
Uresil Valve Cutter with Interchangeable Heads (K930011) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 142 days after the submission was received.
What is the product code of K930011?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.