Rinspiration System
FDA 510(k) K041291 · Kerberos Proximal Solutions, Inc.
510(k) numberK041291
Submission
- Device name
- Rinspiration System
- Applicant
- Kerberos Proximal Solutions, Inc.
Mountain View, CA, US - Received
- May 14, 2004
- Decision date
- May 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135QEZ · Special | 09/20/2006SESU |
| K050130 | Kerberos Proximal Solutions Rispiration SystemQEZ · Traditional | 05/13/2005SESU |
| K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703DQO · Traditional | 08/26/2004SESU |
| K041151 | Kerberos Occluding Guide Catheter and AccessoriesDQY · Traditional | 07/22/2004SE |
| K031485 | Rinspiration SystemDQO · Traditional | 09/25/2003SE |
Questions and answers
When was Rinspiration System cleared by the FDA?
Rinspiration System (K041291) received a 510(k) decision of Substantially Equivalent on May 21, 2004, 7 days after the submission was received.
What is the product code of K041291?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.