Canalizer Hydrophilic Guide Wire
FDA 510(k) K050873 · Medical Device Technologies, Inc.
510(k) numberK050873
Submission
- Device name
- Canalizer Hydrophilic Guide Wire
- Applicant
- Medical Device Technologies, Inc.
Gainesville, FL, US - Received
- April 6, 2005
- Decision date
- May 26, 2005
- 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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Questions and answers
When was Canalizer Hydrophilic Guide Wire cleared by the FDA?
Canalizer Hydrophilic Guide Wire (K050873) received a 510(k) decision of Substantially Equivalent on May 26, 2005, 50 days after the submission was received.
What is the product code of K050873?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.