510(k) · Cleared
ClearedOpti-Plast (Centurion) 5.5F Angioplasty Catheter
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 Jun 19, 1998 as substantially equivalent to K933483 (Vas-Cath, Inc., 1993) and 1 other predicate after a 310-day review. Its family tree reaches back 1 generation to 1993. 13 later devices descend from it.
- Decided
- Jun 19, 1998
- Review
- 310 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933483 (1993). 2 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- This deviceK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- Descendant · 2 generations on · 10 of its ownK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- Descendant · 3 generations on · 9 of its ownK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- Descendant · 4 generations on · 7 of its ownK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- Descendant · 4 generations on · 5 of its ownK122367 Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K040243Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004 · cites it directly11descendants
- K052236Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005 · 2 generations on10descendants
- K120971Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012 · 3 generations on9descendants
- K122984Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012 · 4 generations on7descendants
- K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| 0 (this device) | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| +1 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| +2 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| +3 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| +4 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| +4 | K122367 | Bard PTV Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933483 | Opti-Plast 5F Pta CathetersSummary page 1…t Person's FAX: 770-784-6419 Date of Preparation: June 17, 1998 Device Name: Opti-Plast® Centurion 5.5F PTA Catheter Predicate Device: Opti-Plast® 5.5F PTA Catheter (#K933483) Predicate Device for Indications for Use: Medi-Tech® Blue-Max™ Balloon Dilatation Catheter (#K934191) Device Description: Th… | 1993 |
| * | K934191 | New Blue Max Balloon Dilatation CatheterSummary page 1…F PTA Catheter Predicate Device: Opti-Plast® 5.5F PTA Catheter (#K933483) Predicate Device for Indications for Use: Medi-Tech® Blue-Max™ Balloon Dilatation Catheter (#K934191) Device Description: The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal e… | 1993 |
What descends from it? (13)
See all 132 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?
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 | — |
What is it indicated for?
Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973013: Opti-Plast (Centurion) 5.5F Angioplasty Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973013
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026