Occlusion Balloon Catheter
FDA 510(k) K070126 · Sentreheart, Inc.
510(k) numberK070126
Submission
- Device name
- Occlusion Balloon Catheter
- Applicant
- Sentreheart, Inc.
Palo Alto, CA, US - Received
- January 16, 2007
- Decision date
- February 8, 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
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K153096 | LARIAT RS Suture Delivery DeviceGAT · Special | 11/25/2015SE |
| K142241 | LARIAT sulture Delivery DeviceGAT · Special | 09/12/2014SE |
| K090385 | Lariat II Suture Delivery DeviceGAT · Traditional | 05/06/2009SE |
| K080364 | Findrwirz Guide Wire SystemDQX · Traditional | 08/11/2008SE |
| K060721 | Lariat Loop ApplicatorGAT · Traditional | 06/02/2006SE |
Questions and answers
When was Occlusion Balloon Catheter cleared by the FDA?
Occlusion Balloon Catheter (K070126) received a 510(k) decision of Substantially Equivalent on February 8, 2008, 388 days after the submission was received.
What is the product code of K070126?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.