0.014 Peripheral Guide Wire
FDA 510(k) K882804 · Intensive Technology, Inc.
510(k) numberK882804
Submission
- Device name
- 0.014 Peripheral Guide Wire
- Applicant
- Intensive Technology, Inc.
San Diego, CA, US - Received
- July 7, 1988
- Decision date
- October 28, 1988
- 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
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| 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 |
|---|---|---|
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | 01/13/1993SE |
| K912664 | Tec Rotating Dual HemovalveDYB · Traditional | 08/24/1992SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K903463 | Ivt Introducer SheathDYB · Traditional | 01/03/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | 06/22/1989SE |
| K890515 | Peripheral Atherectomy SystemDWX · Traditional | 05/23/1989SE |
Questions and answers
When was 0.014 Peripheral Guide Wire cleared by the FDA?
0.014 Peripheral Guide Wire (K882804) received a 510(k) decision of Substantially Equivalent on October 28, 1988, 113 days after the submission was received.
What is the product code of K882804?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.