Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J
FDA 510(k) K052578 · Bard Peripheral Vascular, Inc.
510(k) numberK052578
Submission
- Device name
- Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- September 20, 2005
- Decision date
- November 25, 2005
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
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| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional | William Cook Europe Aps | 11/20/2017SE |
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Questions and answers
When was Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J cleared by the FDA?
Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J (K052578) received a 510(k) decision of Unknown on November 25, 2005, 66 days after the submission was received.
What is the product code of K052578?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.