Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System
FDA 510(k) K040037 · Intra Luminal Therapeutics, Inc.
510(k) numberK040037
Submission
- Device name
- Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System
- Applicant
- Intra Luminal Therapeutics, Inc.
Carlsbad, CA, US - Received
- January 9, 2004
- Decision date
- March 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
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| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K040481 | Safe-Cross Deflecting Catheter, Model C118ND1DQY · Special | 03/18/2004SE |
| 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 Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System cleared by the FDA?
Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System (K040037) received a 510(k) decision of Substantially Equivalent on March 3, 2004, 54 days after the submission was received.
What is the product code of K040037?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.