510(k) · Cleared
Recalled · Class II · 2013Vaccess Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 9, 2008 as substantially equivalent to K014212 (C.R. Bard, Inc., 2002) after a 29-day review. Its family tree reaches back 1 generation to 2002. 16 later devices descend from it. It has been recalled once.
- Decided
- Jan 9, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014212 (2002). 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK014212 Bard Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2002
- This deviceK073472 Vaccess Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK102645 Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
- Descendant · cites it directly · 5 of its ownK101047 Pta-Duo Pta Balloon CatheterHotspur Technologies · 2010
- Descendant · 2 generations on · 4 of its ownK113769 Gpscath Ballon Dilatation CatheterHotspur Technologies · 2012
- Descendant · 3 generations on · 3 of its ownK130397 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies · 2013
- Descendant · 2 generations on · 2 of its ownK171251 014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010 · cites it directly6descendants
- K101047Pta-Duo Pta Balloon CatheterHotspur Technologies · 2010 · cites it directly5descendants
- K113769Gpscath Ballon Dilatation CatheterHotspur Technologies · 2012 · 2 generations on4descendants
- K130397Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies · 2013 · 3 generations on3descendants
- K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014212 | Bard Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2002 | — |
| 0 (this device) | K073472 | Vaccess Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | — |
| +1 | K102645 | Willow/Elm Pta Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2010 | — |
| +1 | K101047 | Pta-Duo Pta Balloon Catheter | Hotspur Technologies | 2010 | — |
| +2 | K113769 | Gpscath Ballon Dilatation Catheter | Hotspur Technologies | 2012 | — |
| +3 | K130397 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies | 2013 | — |
| +2 | K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | Creagh Medical | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K014212 | Bard Conquest Pta Balloon Dilatation CatheterSummary page 1…Conquest T M PTA Balloon Dilatation Catheter Device Trade Name: Cleared 510(K) Number: K014212 Date of Cleared 510(K): 01/17/02 Bard Peripheral Vascular, Inc. TRADE SECRE… | 2002 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2013 | Class II | Z-1533-2013 | Mixed-up of materials/components | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x… |
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. 2008, this device’s year, is highlighted.
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?
The VaccessTM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073472: Vaccess Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073472
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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