Super Distal Access (SDA)
FDA 510(k) K161262 · Inneuroco, Inc.
510(k) numberK161262
Submission
- Device name
- Super Distal Access (SDA)
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- May 5, 2016
- Decision date
- September 19, 2016
- 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 |
|---|---|---|
| K232260 | Thinline Sheath IntroducerDYB · Traditional | 09/27/2023SE |
| K220331 | 091 Balloon Guide CatheterDQY · Traditional | 07/29/2022SE |
| K190338 | 046 Zenith FlexNRY · Traditional | 08/02/2019SE |
| K181354 | 074 Zenith Flex SystemNRY · Traditional | 10/25/2018SE |
| K172167 | Zenith Flex SystemNRY · Traditional | 04/19/2018SE |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmDQY · Special | 01/26/2018SE |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmDQY · Traditional | 12/06/2017SE |
| K171672 | 065 Zenith, 074 ZenithDQY · Traditional | 10/19/2017SE |
Questions and answers
When was Super Distal Access (SDA) cleared by the FDA?
Super Distal Access (SDA) (K161262) received a 510(k) decision of Substantially Equivalent on September 19, 2016, 137 days after the submission was received.
What is the product code of K161262?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.