Acs Hi-Torque Tapered Diameter Guide Wire
FDA 510(k) K861574 · Advanced Cardiovascular Systems, Inc.
510(k) numberK861574
Submission
- Device name
- Acs Hi-Torque Tapered Diameter Guide Wire
- Applicant
- Advanced Cardiovascular Systems, Inc.
Mountain View, CA, US - Received
- April 28, 1986
- Decision date
- May 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012534 | Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 01/24/2002SE |
| K000550 | Otw Megalink SDS Biliary Stent SystemFGE · Special | 03/17/2000SESU |
| K994229 | Veripath Peripheral Guiding CatheterDQY · Special | 02/25/2000SE |
| K992169 | Acs Hi-Torque Cross-It 400XT Guide WireDQX · Traditional | 10/28/1999SE |
| K990867 | RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1…FGE · Traditional | 09/02/1999SESU |
| K963702 | Acs Hi-Torque Iron Man Guide WireDQX · Traditional | 01/22/1997SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | 09/12/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | 05/08/1996SESK |
| K955175 | Acs Anchor Exchange DeviceDQX · Traditional | 04/05/1996SE |
| K953987 | Acs Tourgide Guiding CatheterDQY · Traditional | 12/07/1995SE |
Questions and answers
When was Acs Hi-Torque Tapered Diameter Guide Wire cleared by the FDA?
Acs Hi-Torque Tapered Diameter Guide Wire (K861574) received a 510(k) decision of Substantially Equivalent on May 28, 1986, 30 days after the submission was received.
What is the product code of K861574?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.