JetCan® Pro Safety Huber Needle
FDA 510(k) K242763 · Pfm Medical, Inc.
510(k) numberK242763
Submission
- Device name
- JetCan® Pro Safety Huber Needle
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- September 12, 2024
- Decision date
- May 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
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Questions and answers
When was JetCan® Pro Safety Huber Needle cleared by the FDA?
JetCan® Pro Safety Huber Needle (K242763) received a 510(k) decision of Substantially Equivalent on May 2, 2025, 232 days after the submission was received.
What is the product code of K242763?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.