510(k) Report

510(k) · Cleared

Cleared

Spyglass 5 FR Angiographic Catheter

K982299510(k) TraditionalCleared Oct 19, 1998110-day reviewClass II21 CFR 870.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Daig Corp. · DQO Catheter, Intravascular, Diagnostic

Cleared on Oct 19, 1998 as substantially equivalent to K944284 (Daig Corp., 1995) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 1995.

Decided
Oct 19, 1998
Review
110 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944284 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK944284 · Control · Daig Corp. · 1995199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K944284 · Control · Daig Corp. · 19950
  1. Root · 1 generation backK944284 ControlDaig Corp. · 1995
  2. This deviceK982299 Spyglass 5 FR Angiographic CatheterDaig Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944284ControlDaig Corp.1995—
0 (this device)K982299Spyglass 5 FR Angiographic CatheterDaig Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K982299, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K944284Control
Summary page 1
…55345-2126 U.S.A. (612) 933-4700 Michael G. Schultz June 30, 1998 Spyglass ™ 5Fr Angiographic Catheter Angiographic Catheter Spyglass™ Angiographic Catheter Family (K944284, K962805, and K965249) Daig Spyglass™ angiographic catheters are radiopaque polymer reinforced with braided stainless steel. Thi…
Daig Corp.1995—
*K962805Spyglass Angiographic Catheter
Summary page 1
…26 U.S.A. (612) 933-4700 Michael G. Schultz June 30, 1998 Spyglass ™ 5Fr Angiographic Catheter Angiographic Catheter Spyglass™ Angiographic Catheter Family (K944284, K962805, and K965249) Daig Spyglass™ angiographic catheters are radiopaque polymer reinforced with braided stainless steel. This constru…
Daig Corp.1996—

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 DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

The 5Fr Spyglass™ Angiographic Catheter is designed for delivery of radiopaque contrast media during angiographic procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Daig Corp.

63 FDA decisions under this applicant name. See the company

  • K000004Alliance Left Heart Delivery System Introducer, Model #407509Daig Corp. · 2000
  • K994334Ultra-Flex Hemostasis Introducer. Model 406XXXDaig Corp. · 2000
  • K982187Fast-Cath Intra-Cardiac IntroducerDaig Corp. · 19982 recalls
  • K973840Fast-Cath (TM) Intra-Cardiac IntroducerDaig Corp. · 19982 recalls
  • K964518Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 19974 recalls

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K982299 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982299: Spyglass 5 FR Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982299

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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