Wireguide or Guidewire
FDA 510(k) K843012 · Medi-Tech, Inc.
510(k) numberK843012
Submission
- Device name
- Wireguide or Guidewire
- Applicant
- Medi-Tech, Inc.
Watertown, MA, US - Received
- July 31, 1984
- Decision date
- November 29, 1984
- 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 |
|---|---|---|
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | 05/15/1996SE |
| K952345 | Medi-Tech Platform Guide CatheterDQY · Traditional | 08/17/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | 12/13/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was Wireguide or Guidewire cleared by the FDA?
Wireguide or Guidewire (K843012) received a 510(k) decision of Substantially Equivalent on November 29, 1984, 121 days after the submission was received.
What is the product code of K843012?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.