Modification to Hi-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating
FDA 510(k) K020340 · Guidant Corp.
510(k) numberK020340
Submission
- Device name
- Modification to Hi-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating
- Applicant
- Guidant Corp.
Temecula, CA, US - Received
- February 1, 2002
- Decision date
- March 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Modification to Hi-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating cleared by the FDA?
Modification to Hi-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating (K020340) received a 510(k) decision of Substantially Equivalent on March 1, 2002, 28 days after the submission was received.
What is the product code of K020340?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.