Panels › Cardiovascular › Product code OFL · Class 2
Percutaneous Sheath Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (0 all time)
2recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in OFL
| Company | 510(k)s | Recalls |
|---|---|---|
| ARROW INTERNATIONAL, LLC | 0 | 2 |
| Galt Medical Corporation | 0 | 2 |
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PSI KIT: 7 FR X 4 IN/ASK-09701-UP;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5;
PSI KIT: 8.5 FR/ASK-09807-UC;
PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2;
PSI KIT: 9 FR X 10 C Open, Classified |
OFL | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
The Arrow percutaneous sheath introducer permits venous acce Open, Classified |
OFL | None listed |
| May 7, 2025 | Galt Medical Corporation Introducer Kit- Tearaway MicroSlide
REF
KIT-051-01, 00841268106130
INT-101-15, 00841268107380
These introducers are used for the procedures to introduce catheters and other intravascular devices into Open, Classified |
OFL | None listed |
| May 7, 2025 | Galt Medical Corporation Introducer Kit- Coaxial Dilator
REF:
KIT-002-28, 00841268104730
KIT-002-34, 00841268104792
KIT-002-35, 00841268104808
KIT-011-40, 00841268105553
KIT-011-62, 00841268105614
KIT-038-04, 00841268104556
K Open, Classified |
OFL | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular Open, Classified |
OFL | None listed |
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