Spectranetics Quick Cross Extreme Support Catheters
FDA 510(k) K092396 · Spectranetics Corp.
510(k) numberK092396
Submission
- Device name
- Spectranetics Quick Cross Extreme Support Catheters
- Applicant
- Spectranetics Corp.
Colorado Springs, CO, US - Received
- August 5, 2009
- Decision date
- September 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Spectranetics Quick Cross Extreme Support Catheters cleared by the FDA?
Spectranetics Quick Cross Extreme Support Catheters (K092396) received a 510(k) decision of Substantially Equivalent on September 4, 2009, 30 days after the submission was received.
What is the product code of K092396?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.