Reverse Medical Reflex Guide Catheter
FDA 510(k) K110055 · Reverse Medical Corporation
510(k) numberK110055
Submission
- Device name
- Reverse Medical Reflex Guide Catheter
- Applicant
- Reverse Medical Corporation
Irvine, CA, US - Received
- January 10, 2011
- Decision date
- April 5, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K150108 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 04/22/2015SE |
| K141313 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 06/18/2014SE |
| K133282 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Special | 11/27/2013SE |
| K130858 | Reverse Medical MicrocatheterDQY · Traditional | 10/11/2013SE |
| K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Traditional | 07/02/2013SE |
| K122684 | Reverse Medical MicrocatheterDQY · Traditional | 12/07/2012SE |
| K112262 | Reflex Ballon Guide CatheterDQY · Traditional | 11/02/2011SE |
| K102418 | Reverse Medical Report Guide Catheter SystemDQY · Traditional | 04/15/2011SE |
| K091563 | Recruit MicrocatheterMMX · Traditional | 07/30/2009SE |
Questions and answers
When was Reverse Medical Reflex Guide Catheter cleared by the FDA?
Reverse Medical Reflex Guide Catheter (K110055) received a 510(k) decision of Substantially Equivalent on April 5, 2011, 85 days after the submission was received.
What is the product code of K110055?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.