Uresil Subclavian Catheter
FDA 510(k) K863684 · Uresil Corp.
510(k) numberK863684
Submission
- Device name
- Uresil Subclavian Catheter
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- September 19, 1986
- Decision date
- January 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 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 |
| 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 Subclavian Catheter cleared by the FDA?
Uresil Subclavian Catheter (K863684) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 109 days after the submission was received.
What is the product code of K863684?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.