Model 1330 Extension Set
510(k) K873042
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873042 | Date23 Oct 1987 | 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- Withdrawn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, 22 Sep 2026
The Model 1330 Extension Set is a medical device used for intravenous fluid administration. It is designed to connect to infusion systems and facilitate the delivery of fluids to patients.
This extension set is supplied by Pharmacia Deltec, Inc. and is intended for use in general hospital settings. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Other devices from Pharmacia Deltec, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Model 1330 Extension Set used for?
The Model 1330 Extension Set is a medical device designed for intravenous fluid administration. It connects to infusion systems to facilitate the delivery of fluids to patients in general hospital settings.
Is the Model 1330 Extension Set single-use or reusable?
The device data does not specify whether the Model 1330 Extension Set is single-use or reusable. This information would need to be obtained from the manufacturer's instructions for use or product labeling.
What are the regulatory details for the Model 1330 Extension Set?
The Model 1330 Extension Set received FDA 510(k) clearance with K number K873042 on October 23, 1987. It was determined to be substantially equivalent to predicate devices and is classified under product code FPA for general hospital use.
Who manufactures the Model 1330 Extension Set?
The Model 1330 Extension Set is manufactured by Pharmacia Deltec, Inc., located at 1265 Grey Fox Rd., St. Paul, MN 55112. The contact person listed is Edward Numainville.