Attain 6215 Venogram Balloon Catheter
FDA 510(k) K012225 · Medtronic Vascular
510(k) numberK012225
Submission
- Device name
- Attain 6215 Venogram Balloon Catheter
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- July 16, 2001
- Decision date
- August 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
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| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
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| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…DQY · Special | 06/30/2023SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | 04/13/2022SE |
| K192296 | Medtronic 6F Taiga Guiding CatheterDQY · Special | 09/20/2019SE |
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | 11/21/2018SE |
| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
| K171866 | Sentrant Introducer Sheath with Hydrophilic CoatingDYB · Special | 12/20/2017SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
Questions and answers
When was Attain 6215 Venogram Balloon Catheter cleared by the FDA?
Attain 6215 Venogram Balloon Catheter (K012225) received a 510(k) decision of Substantially Equivalent on August 28, 2001, 43 days after the submission was received.
What is the product code of K012225?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.