Micro Guide Catheter XP
FDA 510(k) K082143 · Cordis Corp.
510(k) numberK082143
Submission
- Device name
- Micro Guide Catheter XP
- Applicant
- Cordis Corp.
Warren, NJ, US - Received
- July 30, 2008
- Decision date
- August 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
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| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO · Traditional | 02/17/2022SE |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterLIT · Traditional | 04/23/2021SE |
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| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 10/09/2020SE |
| K201333 | SABER .035 PTA Dilatation CatheterLIT · Traditional | 09/11/2020SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | 08/15/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | 04/18/2018SE |
| K143412 | ADROIT Guiding CatheterDQY · Special | 01/14/2015SE |
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Questions and answers
When was Micro Guide Catheter XP cleared by the FDA?
Micro Guide Catheter XP (K082143) received a 510(k) decision of Substantially Equivalent on August 25, 2008, 26 days after the submission was received.
What is the product code of K082143?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.