Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating
FDA 510(k) K012534 · Advanced Cardiovascular Systems, Inc.
510(k) numberK012534
Submission
- Device name
- Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- August 6, 2001
- Decision date
- January 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| 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 |
| K952205 | Acs Powerbase Guilding CatheterDQY · Traditional | 08/04/1995SE |
Questions and answers
When was Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating cleared by the FDA?
Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating (K012534) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 171 days after the submission was received.
What is the product code of K012534?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.