Infusion Set, Venothin 19
510(k) K781184
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781184 | Date10 Aug 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Infusion Set, Venothin 19 is a peripheral intravenous infusion device designed for administering fluids or medications directly into a patient’s vein. It features a 19-gauge catheter intended for short-term infusion therapy, facilitating controlled fluid delivery in clinical settings such as hospitals or outpatient care. Constructed for single-use, it ensures sterile administration while minimizing the risk of contamination or infection.
This device is supplied sterile and intended for one-time use only, adhering to standard infection control protocols. It is classified under FDA product code FPA and holds a 510(k) clearance (K781184) from the U.S. Food and Drug Administration, affirming its compliance with regulatory standards for infusion systems. Storage requires protection from physical damage and contamination, with expiration dates clearly marked for patient safety. No MRI safety labeling is specified.
Other devices from Venospital, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Infusion Set, Venothin 19 designed for?
The Venothin 19 Infusion Set is specifically designed for administering fluids or medications directly into a patient’s peripheral vein. Its 19-gauge catheter is ideal for short-term infusion therapy, ensuring precise and controlled delivery in clinical environments like hospitals or outpatient settings. The device’s single-use, sterile construction reduces infection risks during administration.
How is the Infusion Set, Venothin 19 supplied and what does that mean for use?
The Venothin 19 Infusion Set is supplied sterile and intended exclusively for single-use. This means each unit is packaged to prevent contamination before use, and it should not be reused or reprocessed. Single-use adherence aligns with infection control protocols to minimize risks during intravenous procedures.
What storage requirements apply to the Venothin 19 Infusion Set?
Storage of the Venothin 19 Infusion Set requires protection from physical damage and contamination. The device includes expiration dates clearly marked on the packaging, which must be respected to ensure patient safety. Proper storage conditions help maintain sterility and functionality until use.
Is the Venothin 19 Infusion Set reusable or intended for single-use?
The Venothin 19 Infusion Set is explicitly designed for single-use only. This design choice is critical for maintaining sterility and reducing infection risks during intravenous therapy. Reusing the device could compromise its integrity and expose patients to potential contamination.
What regulatory clearance does the Venothin 19 Infusion Set hold?
The Venothin 19 Infusion Set holds a 510(k) clearance (K781184) from the U.S. Food and Drug Administration, confirming its compliance with regulatory standards for infusion systems. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use.