Panels › Cardiovascular › Product code OFD · Class 2
Catheter Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (0 all time)
1recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in OFD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C;
2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C Open, Classified |
OFD | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815;
2) ANGIO PACK, Pack Number CVI5045;
3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906;
4) ULTRASOUND Open, Classified |
OFD | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780;
2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920 Open, Classified |
OFD | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020;
b. ARTERIAL LINE TRAY, Model Nu Open, Classified |
OFD | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) CATHETERLESS INSERTION KIT, Model Number CVI4510;
b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B Open, Classified |
OFD | None listed |
| Dec 21, 2022 | Medical Action Industries, Inc. 306 Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit Terminated |
OFD | None listed |
| Oct 6, 2011 | Deroyal Industries, Inc. Lafollette DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA:
Intended Use: Varies by kit; an anesthesia bre Terminated |
OFD | None listed |
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