# K011905: Sniper Elite Model-or-E3872XX Series

- Pathway: 510(k) (Special)
- Applicant: Maxxim Medical
- Decided: Aug 28, 2001 after 70 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 52 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832030 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832030: Heparin Coated Stainless Steel/Teflon, Argon Medical Corp. (1983) Summary page 1.

## Recalls of this device
- Aug 25, 2009 · Not classified · Z-0623-2010: Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
- Feb 26, 2009 · Not classified · Z-1296-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1289-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1304-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1298-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1278-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1306-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1293-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1300-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1301-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1305-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1303-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1281-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1271-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1267-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1276-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1286-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1282-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1270-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1287-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1274-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1275-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1297-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1299-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1272-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1285-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1268-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1307-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1284-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1277-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1269-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1273-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1288-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1291-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1302-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1290-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1279-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1283-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1294-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1292-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1280-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Feb 26, 2009 · Not classified · Z-1295-2009: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Nov 19, 2007 · Not classified · Z-0886-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0882-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0888-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0890-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0884-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0889-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0891-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- Nov 19, 2007 · Not classified · Z-0883-2008: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.

## Indications for use
Sniper Elite Hydrophilic Guidewires are designed for use in angiographic procedures to introduce/position catheters and interventional devices within the vasculature.

Source page: https://510kreport.com/device/K011905
Methodology: https://510kreport.com/methodology