Manan Gwi Guide Wire Introducer
FDA 510(k) K974745 · Medical Device Technologies, Inc.
510(k) numberK974745
Submission
- Device name
- Manan Gwi Guide Wire Introducer
- Applicant
- Medical Device Technologies, Inc.
Gainsville, FL, US - Received
- December 19, 1997
- Decision date
- April 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | 08/27/2010SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | 01/26/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | 08/30/2005SE |
| K050873 | Canalizer Hydrophilic Guide WireDQX · Traditional | 05/26/2005SE |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleKNW · Traditional | 02/11/2005SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | 09/30/2004SE |
| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
| K021606 | En-Snare Endovascular Snare and CatheterMMX · Traditional | 05/31/2002SE |
| K011790 | Microcruiser Plus Introducer SetDYB · Traditional | 09/05/2001SE |
Questions and answers
When was Manan Gwi Guide Wire Introducer cleared by the FDA?
Manan Gwi Guide Wire Introducer (K974745) received a 510(k) decision of Substantially Equivalent on April 6, 1998, 108 days after the submission was received.
What is the product code of K974745?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.