Hi-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper MS Guide Wire with Hydrocoat Hydro
FDA 510(k) K002206 · Guidant Corp.
510(k) numberK002206
Submission
- Device name
- Hi-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper MS Guide Wire with Hydrocoat Hydro
- Applicant
- Guidant Corp.
Santa Clara, CA, US - Received
- July 21, 2000
- Decision date
- August 24, 2000
- 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 Hi-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper MS Guide Wire with Hydrocoat Hydro cleared by the FDA?
Hi-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper MS Guide Wire with Hydrocoat Hydro (K002206) received a 510(k) decision of Substantially Equivalent on August 24, 2000, 34 days after the submission was received.
What is the product code of K002206?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.