Safe-Cross Deflecting Catheter, Model C118ND1
FDA 510(k) K040481 · Intra Luminal Therapeutics, Inc.
510(k) numberK040481
Submission
- Device name
- Safe-Cross Deflecting Catheter, Model C118ND1
- Applicant
- Intra Luminal Therapeutics, Inc.
Carlsbad, CA, US - Received
- February 25, 2004
- Decision date
- March 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 510(k) | Device | Decision |
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| K050916 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]PDU · Special | 06/08/2005SE |
| K050915 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]DQX · Special | 06/07/2005SE |
| K041973 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 08/16/2004SE |
| K040037 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 03/03/2004SE |
| K033929 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 01/12/2004SE |
| K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Traditional | 01/07/2004SE |
| K033708 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 12/11/2003SE |
| K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemPDU · Traditional | 11/21/2003SE |
| K032784 | Ilt Safe-Cross Deflecting Catheter, Model C114ND1DQY · Traditional | 11/18/2003SE |
| K031692 | Safe-Cross Deflecting Catheter, Model C114ND1DQY · Traditional | 08/22/2003SE |
Questions and answers
When was Safe-Cross Deflecting Catheter, Model C118ND1 cleared by the FDA?
Safe-Cross Deflecting Catheter, Model C118ND1 (K040481) received a 510(k) decision of Substantially Equivalent on March 18, 2004, 22 days after the submission was received.
What is the product code of K040481?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.