510(k) · Cleared
Cleared11F Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific /International Technologies · DQY Catheter, Percutaneous
Cleared on Jan 13, 1997 as substantially equivalent to K911869 (Intensive Technology, Inc., 1991) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Jan 13, 1997
- Review
- 122 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K822243 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK822243 Guiding CatheterInterventional Medical, Inc. · 1982
- This deviceK963663 11F Guiding CatheterBoston Scientific /International Technologies · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822243 | Guiding Catheter | Interventional Medical, Inc. | 1982 | — |
| 0 (this device) | K963663 | 11F Guiding Catheter | Boston Scientific /International Technologies | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K911869 | Ivt Guiding CatheterSummary page 1…PREDICATED DEVICES: IVT is claiming substantial equivalence to the following predicate medical devices: 1. InterVentional Technologies, Inc., 5 - 10F Guiding Catheter, K911869 2. Devices for Vascular Intervention, Inc. (DVI), 11F Guiding Catheter 3. Cordis Webster, Inc., Multipurpose Guiding Catheter 4… | 1991 |
| * | K822243 | Guiding CatheterSummary page 1…for Vascular Intervention, Inc. (DVI), 11F Guiding Catheter 3. Cordis Webster, Inc., Multipurpose Guiding Catheter 4. Medtronic Interventional Medical, Guiding Catheter K822243 1. DEVICE DESCRIPTION: The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corres… | 1982 |
| * | — | Devices for Vascular Intervention, Inc. (DVI), 11F Guiding Catheter Named without a submission number | |
| * | — | Cordis Webster, Inc., Multipurpose Guiding Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The IVT 11F Guiding Catheter is a standard guiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and guidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only.
IVT’s 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.
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/K963663 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963663: 11F Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963663
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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