Target Therapeutics Tracker LF Catheter
FDA 510(k) K894105 · Target Therapeutics
510(k) numberK894105
Submission
- Device name
- Target Therapeutics Tracker LF Catheter
- Applicant
- Target Therapeutics
San Jose, CA, US - Received
- June 9, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Target Therapeutics Tracker LF Catheter cleared by the FDA?
Target Therapeutics Tracker LF Catheter (K894105) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 111 days after the submission was received.
What is the product code of K894105?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.