Amplatzer Torqvue Exchange System
FDA 510(k) K080994 · Aga Medical Corp.
510(k) numberK080994
Submission
- Device name
- Amplatzer Torqvue Exchange System
- Applicant
- Aga Medical Corp.
Plymouth, MN, US - Received
- April 7, 2008
- Decision date
- May 16, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K121611 | Amplatzer Torqvue FXDQY · Traditional | 08/23/2012SE |
| K113658 | Amplatzer Vascular Plug 4KRD · Traditional | 06/12/2012SE |
| K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…DQY · Special | 03/15/2012SE |
| K093476 | Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…DQY · Traditional | 02/05/2010SE |
| K091793 | Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54DQY · Special | 07/09/2009SE |
| K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…DQY · Special | 05/12/2009SE |
| K080757 | Amplatzer Torqvue Low Profile Delivery SystemDQY · Special | 04/18/2008SE |
| K072313 | Amplatzer Torqvue Delivery SystemDQY · Traditional | 11/02/2007SE |
| K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022KRD · Special | 08/15/2007SE |
| K071125 | Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…KRD · Special | 06/18/2007SE |
Questions and answers
When was Amplatzer Torqvue Exchange System cleared by the FDA?
Amplatzer Torqvue Exchange System (K080994) received a 510(k) decision of Substantially Equivalent on May 16, 2008, 39 days after the submission was received.
What is the product code of K080994?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.