Kerberos Occluding Guide Catheter and Accessories
FDA 510(k) K041151 · Kerberos Proximal Solutions, Inc.
510(k) numberK041151
Submission
- Device name
- Kerberos Occluding Guide Catheter and Accessories
- Applicant
- Kerberos Proximal Solutions, Inc.
Mountain View, CA, US - Received
- May 3, 2004
- Decision date
- July 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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|---|---|---|
| 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 |
| K041291 | Rinspiration SystemDQO · Special | 05/21/2004SE |
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Questions and answers
When was Kerberos Occluding Guide Catheter and Accessories cleared by the FDA?
Kerberos Occluding Guide Catheter and Accessories (K041151) received a 510(k) decision of Substantially Equivalent on July 22, 2004, 80 days after the submission was received.
What is the product code of K041151?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.