Occlusion Balloon Catheter, Model Venos
FDA 510(k) K081052 · Oscor, Inc.
510(k) numberK081052
Submission
- Device name
- Occlusion Balloon Catheter, Model Venos
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- April 14, 2008
- Decision date
- June 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
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| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
| K012225 | Attain 6215 Venogram Balloon CatheterDYG · Traditional | Medtronic Vascular | 08/28/2001SE |
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Questions and answers
When was Occlusion Balloon Catheter, Model Venos cleared by the FDA?
Occlusion Balloon Catheter, Model Venos (K081052) received a 510(k) decision of Substantially Equivalent on June 18, 2008, 65 days after the submission was received.
What is the product code of K081052?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.