FDA product code OFC: Catheter Introducer Kit
OFC is the FDA product code for catheter introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under OFC. The average 510(k) review took 158 days (median 158). FDA has posted 4 recalls for OFC devices, 3 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Catheter Introducer Kit |
| Device class | Class II |
| Regulation | 21 CFR 870.1340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OFC clearance
Top OFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spectranetics Corp. | 1 | 2010-03-26 |
Most recent OFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093257 | Spectranetics Corp. | TORQMAX SHEATH GRIP ACCESSORY | 2010-03-26 | 158 |
Recalls for OFC devices
4 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code OFC?
OFC is the FDA product code for catheter introducer kit. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel.
What device class is OFC?
Class II, regulation 21 CFR 870.1340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OFC?
Across 1 cleared submissions the average was 158 days from receipt to decision (median 158).
Which companies have the most OFC clearances?
Spectranetics Corp. (1).
Have OFC devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OFC
- Run a recall and safety report across every OFC manufacturer
- Watch product code OFC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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