510(k) · Cleared
ClearedOpti-Plast 5F Pta Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vas-Cath, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Sep 24, 1993 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Sep 24, 1993
- Review
- 86 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- Descendant · cites it directly · 13 of its ownK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- Descendant · 2 generations on · 11 of its ownK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- Descendant · 3 generations on · 10 of its ownK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- Descendant · 4 generations on · 9 of its ownK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- Descendant · 5 generations on · 7 of its ownK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K973013Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998 · cites it directly13descendants
- K040243Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004 · 2 generations on11descendants
- K052236Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005 · 3 generations on10descendants
- K120971Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012 · 4 generations on9descendants
- K122984Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| +1 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| +2 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| +3 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| +4 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| +5 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973013 (Vas-Cath, Inc., 1998) has gone furthest, with 13 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
https://510kreport.com/device/K933483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933483: Opti-Plast 5F Pta Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933483
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026