Percutaneous Catheters
FDA 510(k) K861008 · Micor, Inc.
510(k) numberK861008
Submission
- Device name
- Percutaneous Catheters
- Applicant
- Micor, Inc.
Pittsburgh, PA, US - Received
- March 18, 1986
- Decision date
- April 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 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 |
|---|---|---|
| K031600 | Conduction CatheterFRN · Traditional | 08/13/2003SE |
| K003966 | Wundcath Conduction CatheterFRN · Traditional | 07/17/2001SE |
| K001717 | Micor Conduction CatheterBSO · Traditional | 09/20/2000SE |
| K001940 | Micor Anesthesia Conduction KitCAZ · Traditional | 08/11/2000SE |
| K991879 | Spring-Wound Epidural CatheterBSO · Traditional | 10/28/1999SE |
| K860339 | Percutaneous CathetersDQY · Traditional | 03/31/1986SE |
| K854018 | Angiography CathetersDQO · Traditional | 01/16/1986SE |
Questions and answers
When was Percutaneous Catheters cleared by the FDA?
Percutaneous Catheters (K861008) received a 510(k) decision of Substantially Equivalent on April 29, 1986, 42 days after the submission was received.
What is the product code of K861008?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.