510(k) · Cleared
ClearedOPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 7, 1997 after a 90-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Oct 7, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK972825 OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter…Cordis Corp. · 1997
- Descendant · cites it directly · 11 of its ownK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
- Descendant · 2 generations on · 7 of its ownK012050 Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001
- Descendant · cites it directly · 7 of its ownK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- Descendant · 3 generations on · 6 of its ownK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- Descendant · 4 generations on · 4 of its ownK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K983055RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Guidant Corp. · 1998 · cites it directly11descendants
- K012050Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp. · 2001 · 2 generations on7descendants
- K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998 · cites it directly7descendants
- K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · 3 generations on6descendants
- K102705Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972825 | OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond… | Cordis Corp. | 1997 | — |
| +1 | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20… | Guidant Corp. | 1998 | — |
| +2 | K012050 | Viatrac 14 Plus Peripheral Dilatation Catheter | Guidant Corp. | 2001 | — |
| +1 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| +3 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| +4 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Cordis Opta5 PTA Balloon Catheter Named without a submission number | |
| * | — | Cordis Powerflex PTA Balloon Catheter Named without a submission number | |
| * | — | Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter Named without a submission number | |
| * | — | Cordis Palmaz and Palmaz-Schatz Balloon Expandable Stents Named without a submission number |
What descends from it? (20)
See all 203 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, K983055 (Guidant Corp., 1998) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
Opta5 PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, popliteal and renal arteries.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz Balloon Expandable Stents for the biliary system.
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/K972825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972825: OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972825
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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