Clearance Summary
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER received FDA 510(k) clearance under submission number K930606, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-09-10.
- Submission: K930606
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4545
- Decision date: 1993-09-10
Classification & Regulation
This clearance is catalogued under FDA product code GYK and 21 CFR 882.4545, within the Neurology review panel as a Class I device.