Spectranetics 0.035 Support Catheter, Model 518-028
FDA 510(k) K022138 · Spectranetics Corp.
510(k) numberK022138
Submission
- Device name
- Spectranetics 0.035 Support Catheter, Model 518-028
- Applicant
- Spectranetics Corp.
Colorado Springs, CO, US - Received
- July 2, 2002
- Decision date
- September 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 0.035 Support Catheter, Model 518-028 cleared by the FDA?
Spectranetics 0.035 Support Catheter, Model 518-028 (K022138) received a 510(k) decision of Substantially Equivalent on September 23, 2002, 83 days after the submission was received.
What is the product code of K022138?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.